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Hand Washing, Cleaning,Disinfection andSterilization in
Health Care
Supplement
Date of Publication: December 1998
Volume 24S8
Canada Communicable Disease Report
ISSN 1188-4169
infection control guidelines
Our mission is to help the people of Canadamaintain and improve their health
Health Canada
This publication was produced by the Document DisseminationDivision at the Laboratory Centre for Disease Control, HealthCanada.
To obtain additional copies or subscribe to the CanadaCommunicable Disease Report, please contact the Member ServiceCentre, Canadian Medical Association, 1867 Alta Vista Drive,Ottawa, ON, Canada K1G 3Y6, Tel.: 888-855-2555 or by FAX:(613) 731-9102.
This publication can also be accessed electronically via Internetusing a Web browser at http://www.hc-sc.gc.ca/hpb/lcdc
Infection Control Guidelines
Hand Washing, Cleaning, Disinfection and Sterilization in Health Care
Health CanadaLaboratory Centre for Disease Control
Bureau of Infectious DiseasesNosocomial and Occupational Infections
Introductory Statement
The primary objective in developing clinicalguidelines at the national level is to help health careprofessionals improve the quality of health care.Guidelines for the control of infection are needed toassist in developing policies, procedures and evaluativemechanisms to ensure an optimal level of care.Guidelines facilitate the setting of standards but respectthe autonomy of each institution and recognize thegoverning body’s authority and responsibility ofensuring the quality of patient/client care provided by the institution.
The guidelines, whenever possible, have been basedon research findings. Where there is insufficientpublished research, consensus of experts in the field hasbeen utilized to provide guidelines specific toconventional practice. The encouragement of researchand frequent revision and updating are necessary ifguidelines are to remain relevant and useful.
The Steering Committee acknowledges, with sincereappreciation, the many practising health professionalsand others who contributed advice and information tothis endeavour.
The guidelines outlined herein are part of a series thathas been developed over a period of years under theguidance of the Steering Committee on Infection Control Guidelines. Infection Control Guidelines for HandWashing, Cleaning, Disinfection and Sterilization inHealth Care presents an overview and providesrecommendations to assist in preventing the transmission of infection in health care facilities. This document ispart of the Health Canada series of Infection ControlGuidelines and is intended to be used with the otherInfection Control Guidelines, which include thefollowing:
Preventing the Transmission of Bloodborne Pathogens in Health Care and Public Services Settings (1997)
Isolation and Precaution Techniques (1990) (underrevision - to be published March, 1999)
Preventing the Spread of Vancomycin-ResistantEnterococci (1997)
Preventing the Transmission of Tuberculosis inCanadian Health Care Facilities and Other InstitutionalSettings (1996)
Canadian Contingency Plan for Viral HemorrhagicFevers and Other Related Diseases (1997)
Prevention of Infections Associated with IndwellingIntravascular Access Devices (1997)
Foot Care by Health Care Providers (1997)
Occupational Health in Health Care Facilities (1990)(under revision)
Prevention of Nosocomial Pneumonia (1990) (underrevision)
Long Term Care Facilities (1994)
Antimicrobial Utilization in Health Care Facilities(1990)
Prevention of Surgical Wound Infections (1990)
Prevention of Urinary Tract Infections (1990)
Perinatal Care (1988)
Organization of Infection Control Programs in HealthCare Facilities (1990)
iii
For information regarding these Health Canadapublications, contact:
Division of Nosocomial and Occupational InfectionsBureau of Infectious Diseases
Laboratory Centre for Disease ControlHealth Canada, PL 0603E1Ottawa, Ontario K1A 0L2Telephone: (613) 952-9875Fax: (613) 998-6413
iv
Steering Committee on Infection Control Guidelines
STEERING COMMITTEE MEMBERS
Dr. Lindsay Nicolle (Chair)H.E. Sellers Professor and ChairDepartment of Internal MedicineUniversity of Manitoba Health Sciences CentreGC 430, 820 Sherbrooke StreetWinnipeg, ManitobaR3A 1R9Tel: (204) 787-7772Fax: (204) 787-4826e mail: [email protected]
Dr. John ConlyHospital Epidemiologist and Associate Professor
of MedicineThe Toronto Hospital, Room 117A-NU13 200 Elizabeth StreetToronto, OntarioM5G 2C4Tel: (416) 340-4858Fax: (416) 340-5047e mail: [email protected]
Dr. Charles FrenetteHôpital Charles Lemoyne121 Taschereau Blvd.Greenfield Park, QcJ4V 2H1Tel: (514) 466-5000 locale 2834Fax: (514) 466-5778
Agnes HonishManager, Communicable Disease ControlCapital Health AuthorityCommunity and Public HealthSuite 300, 10216 - 124th StreetEdmonton, AlbertaT5N 4A3
Tel: (403) 413-7944Fax: (403) 413-7950
Dr. B. Lynn JohnstonHospital Epidemiologist and Associate Professor
of MedicineQueen Elizabeth II Health Sciences Centre,
Room 5-014 ACC1278 Tower RoadHalifax, N.S.B3H 2Y9Tel: (902) 473-8477Fax: (902) 473-7394
Linda KingsburyNurse ConsultantNosocomial and Occupational InfectionsBureau of Infectious Diseases, Health CanadaLaboratory Centre for Disease Control, 0603E1Tunney’s PastureK1A 0L2Tel: (613) 957-0328Fax: (613) 998-6413 e mail: [email protected]
Louise MeunierConseillère en prévention des infectionsPrévention des infectionsHôpital Saint-Luc1058 rue St. DenisMontréal, QuébecH2X 3J4Tel: (514) 281-3255, ext 5902Fax: (514) 281-3293
v
Catherine MindorffCommunity and Institutional Infection Prevention
and Control202 Yahara PlaceAncaster, OntarioL9G 1Y5Tel: (905) 304-1196Fax: (905) 304-1999
Dr. Dorothy MooreDivision of Infectious DiseasesMontreal Children’s Hospital2300 TupperMontréal, QuébecH3H 1P3Tel: (514) 934-4485Fax: (514) 934-4494e mail: [email protected]
Laurie O’NeilInfection Prevention Consultant4908 Nelson Rd. N.W.Calgary, AlbertaT2K 2L9Tel: (403) 282-2340
Shirley PatonChief, Nosocomial and Occupational InfectionsBureau of Infectious Diseases, Health CanadaLaboratory Centre for Disease Control, 0603E1Ottawa, Ontario K1A 0L2Tel: (613) 957-0326Fax: (613) 998-6413e mail: [email protected]
Diane PhippenEpidemiologist Nurse CoordinatorCadham Provincial LaboratoryBox 8450, 750 William AvenueWinnipeg, ManitobaR3C 3Y1Tel: (204) 945-6685 (direct line)
(204) 945-6123 (switchboard)Fax: (204) 786-4770
LIAISON REPRESENTATIVES
Association des médecins microbiologistesinfectiologues du Québec (AMMIQ)
Dr. Charles Frenette
Association pour la prévention des infections à l’hôpitalet dans la communauté (APPI)
Yolaine Rioux, Monique Delorme
Canadian Association for Clinical Microbiology andInfectious Diseases (CACMID)
Dr. Mary Vearncombe
Canadian Council on Health Services AccreditationMrs. Marilyn Colton, Assist. Executive Director
Canadian Healthcare AssociationRosa Paliotti, Barbara Lyons
Canadian Infectious Disease Society (CIDS)Dr. Gary Garber, Dr. John Conly
The Community and Hospital Infection ControlAssociation - Canada (CHICA Canada)
Deborah Norton, Clare Barry
EX-OFFICIO MEMBER
Dr. John SpikaDirectorBureau of Infectious DiseasesLaboratory Centre for Disease Control, 0603E1Health CanadaOttawa, OntarioK1A 0L2Tel: (613) 957-4243Fax: (613) 998-6413
MEMBERS OF SUBCOMMITTEE ONHAND WASHING, CLEANING,DISINFECTION AND STERILIZATION INHEALTH CARE
Agnes Honish (Chair)Manager, Communicable Disease ControlCapital Health AuthorityCommunity and Public Health Suite 300, 10216 - 124 StreetEdmonton, AlbertaT5N 4A3Tel: (403) 413-7944Fax: (403) 413-7950
Dr. Gloria DelisleDirector, Medical MicrobiologyQueen’s University116 Brock StreetKingston, OntarioK7L 5G2Tel: (613) 544-3400Fax: (613) 531-7953
vi
Dr. Lynn JohnstonHospital Epidemiologist and Associate Professor of
MedicineQueen Elizabeth II Health Sciences Centre,
Room 5-014 ACC1278 Tower RoadHalifax, Nova ScotiaB3H 2Y9Tel: (902) 473-8477Fax: (902) 473-7394
Linda KingsburyNurse ConsultantNosocomial and Occupational InfectionsBureau of Infectious Diseases, Health CanadaLaboratory Centre for Disease Control, 0603E1Tunney’s PastureK1A 0L2Tel: (613) 957-0328Fax: (613) 998-6413 e mail: [email protected]
Susan LaffertyInfection Control PractitionerRoyal Alexandra Hospital10240 KingswayEdmonton, AlbertaT5H 3V9Tel: (413) 491-5864Fax: (403) 491-5886
Maureen MillerInfection Control ManagerCaritas Health Group1100 Youville Drive, WestEdmonton, AlbertaT6L 5X8
Tel: (413) 450-7308Fax: (403) 450-7259
Pat PiaskowskiThunder Bay Regional Hospital325 S. Archibald St.Thunder Bay, OntarioP7E 1G6Tel: (807) 343-7123Fax: (807) 343-7165e mail: [email protected]
Dr. Syed SattarProfessor of Microbiology and DirectorCentre for Research on Environmental MicrobiologyFaculty of MedicineUniversity of OttawaOttawa, OntarioTel: (613) 562-5800, ext. 8314Fax: (613) 562-5452
Dr. Ann SkidmoreMedical MicrobiologistSurrey Memorial Hospital13750 - 96th AvenueSurrey, British ColumbiaV3V 1Z2Tel: (604) 581-2211Fax: (604) 588-3322
The Steering Committee gratefully acknowledges theassistance of the Editorial and Production Unit,Document Dissemination Division, LCDC, HealthCanada, and Translation Services, Montreal.
vii
Table of Contents
HAND WASHING AND GLOVES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
A. Microbiology of the Skin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
B. Soaps and Antiseptic Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
C. Waterless Hand Scrubs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
D. Hand Washing Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Table 1. Soaps and Antimicrobial Agents for Hand Washing . . . . . . . . . . . . . . . . . . . . . . 3
Table 2. Characteristics of Antiseptic Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
E. Compliance with Hand Washing Protocols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Table 3. How to Wash Hands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Table 4. Proposed Strategies to Improve Hand Washing Technique and Compliance . . . . . . . . . 6
Recommendations on Hand Washing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
F. Gloves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
i) Glove use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
ii) Selection of gloves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
iii) Glove types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
iv) Problems of glove use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Recommendations on Glove Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
CLEANING, DISINFECTING AND STERILIZING PATIENT CARE EQUIPMENT . . . . . . . . . . . 10
A. Classification of Medical Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
B. Cleaning Equipment and Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Table 5. Reprocessing of Commonly Used Equipment in Health Care Settings
in Usual Situations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
i) Sorting and soaking. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
ii) Removal of organic material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
iii) Rinsing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
iv) Drying . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
ix
C. Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
i) Chemical disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
ii) Relative resistance of microorganisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
iii) Creutzfeldt-Jakob disease (CJD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Figure 1. Classes of Microorganisms Ranked in Descending Order from
Least to Most Susceptible to Chemical Disinfectants. . . . . . . . . . . . . . . . . . . . . 14
Table 6. Major Classes of Chemical Disinfectants and their Relative
Advantages and Disadvantages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Table 7. Directions for Preparing and Using Chlorine-based Disinfectants. . . . . . . . . . . . . . 17
iv) Reuse of chemical disinfectants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
v) Disinfectants and safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
vi) Registration of disinfectants in Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
vii) Product labelling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
viii) Pasteurization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
ix) Ultraviolet radiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
x) Boiling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
xi) Sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
xii) New technologies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
xiii) Monitoring of the sterilization cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Table 8. Advantages and Disadvantages of Currently Available Sterilization Methods. . . . . . . . 21
xiv) Maintenance of sterility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
a. Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
b. Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Recommendations on Cleaning, Disinfection and Sterilization. . . . . . . . . . . . . . . . . . . . . . . 25
MICROBIOLOGIC SAMPLING OF ENVIRONMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Recommendations for Microbiologic Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
HOUSEKEEPING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
A. Routine Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Table 9. Cleaning Procedures for Common Items. . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Recommendations for Routine Housekeeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
B. Special Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
i) Special organisms of epidemiologic significance . . . . . . . . . . . . . . . . . . . . . . . . 32
ii) Blood spills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Recommendations for Cleaning Blood Spills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
iii) Surgical settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Recommendations for Cleaning Surgical Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
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LAUNDRY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Recommendations for Laundry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
1. Collection and handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
2. Bagging and containment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
3. Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
4. Washing and drying . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
5. Dry cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
6. Sterile linen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
7. Protection of laundry workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
WASTE MANAGEMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
A. Public Health Risk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Table 10. Recommendations for Management of Untreated Infectious Waste . . . . . . . . . . . . . . . 38
B. Treatment of Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
i) Chemical decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
ii) Steam sterilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
C. Disposal Methods for Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
i) Landfill . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
ii) Sanitary sewer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
iii) Incineration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
D. Safety for Waste Handlers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Recommendations for Waste Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Appendix 1. Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Appendix 2. Guideline Rating System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Table 11. Strength and Quality of Evidence for Recommendations . . . . . . . . . . . . . . . . . . . . 54
Appendix 3. Drugs Directorate Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
xi
Hand Washing and Gloves*
Disease-causing microorganisms can frequently beisolated from the hands. Hand carriage of bacteria is animportant route of transmission of infection betweenpatients or from the health care worker to thepatient/client(1-6). Appropriate hand washing results in areduced incidence of both nosocomial and communityinfections(1,7,8). Guidelines from national and inter-national infection prevention and control organizationshave repeatedly acknowledged that hand washing is thesingle most important procedure for preventinginfections(9-11). Despite this, health careproviders’compliance with hand washing is poor(12-14).
This section will review the current literature on skinflora, antimicrobial agents used for hand antisepsis, hand washing techniques and other aspects of hand care andprotection, and will make recommendations to be applied in the health care setting. Routine hand washing isdiscussed in this guideline, and the surgical hand scrub is discussed in Infection Control Guidelines: Prevention ofSurgical Wound Infections(15).
A. Microbiology of the SkinLarson has provided an extensive review of the
physiologic and bacteriologic characteristics of theskin(16). The finger nail area is associated with a majorportion of the hand flora. The subungual areas (locatedunder the fingernail) often harbour high numbers ofmicroorganisms, which may serve as a source ofcontinued shedding, especially under gloves(17).
Artificial nails(18) and chipped nail polish(19) may beassociated with a further increase in the number ofbacteria on fingernails.
The microbial flora of the skin consist of resident(colonizing) and transient (contaminating) micro-organisms. The resident microorganisms survive andmultiply on the skin. Resident flora include thecoagulase-negative staphylococci, members of the genusCorynebacterium (diphtheroids or coryneforms),Acinetobacter species, and occasionally members of theEnterobacteriaceae group(20). Resident skin micro-organisms are not usually implicated in nosocomialinfections, other than minor skin infections; however,some can cause infections after invasive procedures,when the patient/client is severely immunocompromisedor has an implanted device, such as a heart valve orartificial hip.
The transient microbial flora represent recentcontaminants of the hands acquired from colonized orinfected patients/clients or contaminated environment orequipment. Transient microorganisms are notconsistently isolated from most persons. In contrast tothe resident flora, the transient microorganisms found onthe hands of health care personnel are more frequentlyimplicated as the source of nosocomial infections. Themost common transient flora include gram negativecoliforms and Staphylococcus aureus.
Hand washing with plain soap (detergents) is effective in removing most transient microbial flora(20-22). Thecomponents of good hand washing include using anadequate amount of soap, rubbing the hands together to create some friction, and rinsing under runningwater. The mechanical action of washing, rinsing anddrying removes most of the transient bacteria present(23-25).
1
* See Appendix 1 for definitions of the following terms: antimicrobial agent, antiseptic, hand wash(ing), hand antisepsis, heavy microbialsoiling, plain or nonantimicrobial soap, sharps, surgical hand scrub.
In some studies, air dryers have been shown to reducethe number of organisms on hands after hand washing(26-28).Several studies have demonstrated that air hand dryersare unsuitable for use in critical patient care areasbecause of the potential for cross infection, eitherthrough airborne dissemination or contaminatedpersonnel(24,29-31). Air dryers may be an impediment tohand drying because of the time taken to dry hands andthe need to ensure that the equipment is functioning.
B. Soaps and Antiseptic AgentsThe purpose of hand washing is to remove soil,
organic material and transient microorganisms from theskin. Few clinical studies have defined the absoluteindications for hand washing with plain soaps(detergents) versus hand antisepsis with antimicrobialproducts. Controlled trials have not documenteddecreased infection with the use of an antiseptic agentover plain soap for routine hand washing in the generalhealth care setting. The degree of reduction in microbialnumbers on the hands of health care providers necessaryto protect the recipient of care has not been defined. Afew studies have suggested that antiseptic agents may bepreferable for the care of patients if there is a possibilityof antimicrobial-resistant organisms, such as in intensivecare units(3,32), in the presence of antimicrobial-resistantorganisms(33-36), and under conditions of heavy microbialsoiling (e.g., in the presence of infection or a high levelof contamination with organic matter such as feces)(37).
Understanding the distinctive ingredients and uses ofthe soap and antiseptic products available is important inchoosing the appropriate agent for the appropriatesituation. If an antiseptic product is used, it should beselected for its chemical composition, its type andspectrum of activity, its onset and duration of activity,the application for which it will be used, its cost,allergenic potential and acceptability to the users.Whatever product is used, it should be applied at theright dilution for the recommended time with standardmethods of application.
Antiseptic hand cleansers are designed to rapidlywash off the majority of the transient flora by theirmechanical detergent effect and to exert an additionalsustained antimicrobial activity on the resident hand flora (Tables 1 and 2)(38,39).
C. Waterless Hand ScrubsSeveral studies have demonstrated superior efficacy of
waterless hand scrubs compared with hand washing with
soap and water or chlorhexidine(36,47-50). Alcohol-basedcompounds for hand antisepsis predominate in severalEuropean countries(51-53). Alcohol preparations offerrapid reduction in microbial counts on skin(54): avigorous, 1-minute rubbing with enough alcohol to wetthe hands completely has been shown to be an effectivemethod of hand antisepsis(20,36,51,55,56). Alcoholapplications as short as 15 seconds in duration have been effective in preventing hand transmission of gram-negative bacteria(37,57). The advantages of alcohol rubsinclude the following: (1) they have an immediate anddelayed antimicrobial performance, (2) no wash basin isnecessary for their use and (3) alcohol rubs can beconveniently available near every patient/client and aremore practical when there is insufficient time to washhands(42,57,58). Alcohol preparations are useful in homecare when proper facilities for hand washing may belacking(59).
A major disadvantage of alcohol for skin antisepsis isits effect on the user. Waterless hand scrubs may have adrying effect on the skin of the hands, and productodours may be irritating for health care workers. Theaddition of emollients to minimize skin drying increasesthe acceptability of alcohol-based solutions on thehands(55). The antimicrobial efficacy of alcohols issensitive to dilution with water, therefore alcoholpreparations must be rubbed onto dry hands(55). Theactivity of alcohol does not appear to be significantlyaffected by small amounts of blood(60); however, furtherstudies are needed to determine activity in the presenceof large amounts of organic matter.
See Table 2 for a description of the antimicrobialactivity and uses of antiseptic agents.
D. Hand Washing TechniquesThe absolute indications for and the ideal frequency of
hand washing have not been well studied. Theindications for hand washing depend on
(a) the type, intensity, duration and sequence ofactivity;
(b) the degree of contamination associated with thecontact; and
(c) the susceptibility to infection of the health carerecipient.
2
Table 1. Soaps and Antiseptic Agents for Hand Washing
Product Indications Special considerations
Plain soap, bar soap,
liquid*, granules
For routine care of patients/residents/clients (10,20,40)
For washing hands soiled with dirt, blood or other organicmaterial
May contain very low concentrations of antimicrobial agents toprevent microbial contamination growth in the product.
Bar soap should be on racks that allow water to drain; small bars that can be changed frequently are safest(11,41).
Waterless antiseptic agents:
- rinses
- foams
- wipes
- towelettes
Demonstrated alternative to conventional agents(42)
For use where hand washing facilities are inadequate,impractical or inaccessible (e.g., ambulances, home care, massimmunization)
For situations in which the water supply is interrupted (e.g.,planned disruptions, natural disasters)
Not effective if hands are soiled with dirt or heavily contaminatedwith blood or other organic material.
Follow manufacturer’s recommendations for use.
Efficacy affected by concentration of alcohol in product.
Hand creams should be readily available to protect skin integrity(43-45).
Antiseptic agents Refer to recommendations at end of this chapter.
May be chosen for hand scrubs prior to performance of invasive procedures (e.g., placing intravascular lines or devices)(34).
When caring for severely immunocompromised individuals
Based on risk of transmission (e.g., specific microorganisms)
Critical care areas
Intensive care nurseries
Operating room scrub
When caring for individuals with antimicrobial resistantorganisms(33)
Antiseptic agents may be chosen if it is felt important to reduce thenumber of resident flora or when the level of microbialcontamination is high.
Antiseptic agents should be chosen when persistent antimicrobialactivity on the hands is desired.
They are usually available in liquid formulations*.
Antiseptic agents differ in activity and characteristics(38,39).
Routine use of hexachlorophene is not recommended because ofneurotoxicity and potential absorption through the skin(46).
Alcohol containers should be stored in areas approved for flammable materials.
* Disposable containers are preferred for liquid products. Reusable containers should be thoroughly washed and dried before refilling, and routine maintenance schedules should be followed and documented.Liquid products should be stored in closed containers and should not be topped-up.
Table 2. Characteristics of Antiseptic Agents
Group andsubgroup
Gram-positivebacteria
Gram-negativebacteria
Mycobacteriumtuberculosis
Fungi VirusSpeed of killing
sensitivebacteria
Inactivated by mucus orproteins
Comments
Alcohols Good Good Good Good Good Fast Moderate Optimum strength 70% to 90% with addedemollients (glycerine or cetyl alcohol is lessdrying), not recommended for physical cleaningof skin; good for hand antisepsis and for surgicalsite preparation.
Chlorhexidine
2% and 4%aqueous
Good Good Fair Fair Good Intermediate Minimal Has persistent effect; good for both handwashing and surgical site or preoperative patientskin preparation; do not use near mucousmembranes; toxic effects on ears and eyesreported; activity neutralized by nonionicsurfactants.
Hexachloro-
phene 3%aqueous
Good Poor Poor Poor Poor Slow Minimal Provides persistent, cumulative activity afterrepeated use (washing with alcohol reducespersistent action), can be toxic when absorbedfrom skin especially in premature infants; goodfor hand washing but not for surgical sitepreparation; limited spectrum of antimicrobialactivity.
Iodinecompounds,iodine inalcohol
Good Good Good Good Good Fast Marked Causes skin “burns,” but this is unusual with 1%tincture, especially if it is removed after severalminutes; too irritating for hand washing butexcellent for surgical site preparation.
Iodophors Good Good Fair Good Good Intermediate Moderate Less irritating to the skin than iodine; good forboth hand washing and surgical site preparation;rapidly neutralized in presence of organicmaterials such as blood or sputum
Para-chloro-
meta-xylenol
(PCMX)
Good Fair* Fair Fair Fair Intermediate Minimal Activity neutralized by nonionic surfactants
Triclosan Good Good Fair Poor Good Intermediate Minimal
*Activity improved by addition of chelating agent such as EDTA.Note: Some of these agents, such as iodine or chlorhexidine, are combined with alcohol to form tinctures and are available in the combined formulation(10).Table used with permission of author and publisher(10).
5
Table 3. How to Wash Hands
Procedure Rationale
Remove jewelry before hand wash procedure(38,61).
Rinse hands under warm running water. This allows for suspension and washing away of the loosenedmicroorganisms.
Lather with soap and, using friction, cover all surfaces of thehands and fingers.
The minimum duration for this step is 10 seconds(25); more time may be required if hands are visibly soiled.
For antiseptic agents 3-5 mL are required(38).
Frequently missed areas are thumbs, under nails, backs offingers and hands.
Rinse under warm running water. To wash off microorganisms and residual hand washing agent
Dry hands thoroughly with single-use towel or forced air dryer. Drying achieves a further reduction in number ofmicroorganisms(24,29,38).
Reusable towels are avoided because of the potential formicrobial contamination.
Turn off faucet without recontaminating hands. To avoid recontaminating hands.
Do not use fingernail polish or artificial nails. Artificial nails or chipped nail polish may increase bacterialload and impede visualization of soil under nails(18,62).
The efficacy of a hand wash depends on the timetaken and the technique. The recommended handwashing technique is outlined in Table 3. It is importantto avoid potential microbial contamination by splashingof clothing, other skin surfaces or inanimate items during hand washing.
E. Compliance with Hand Washing ProtocolsAlthough hand washing is considered the most
important single intervention for preventing nosocomialinfections(1-6), studies have repeatedly shown poorcompliance with hand washing protocols by hospitalpersonnel(3,12,13,63,64). Failure to comply is a complexproblem that includes elements of lack of motivation and
lack of knowledge about the importance of hand wash-ing. It may also be due to real or perceived obstacles,such as understaffing, inconveniently located handwashing facilities, an unacceptable hand washing product or dermatitis caused by previous hand washing. Anumber of strategies have been suggested to improvecompliance (Table 4). Long-term success will requiredevelopment of programs and sustained efforts atpromoting compliance with hand washing. Effectiveinterventions will probably be multidimensional, and will require the application of behavioural science theorycombined with engineering and/or productinnovation(7,8).
Recommendations on Hand Washing
1. Hands must be washed
(i) between direct contact with individualpatients/residents/clients;
(ii) before performing invasive procedures(11,20);
(iii) before caring for patients in intensive care unitsand immunocompromised patients(11,20);
(iv) before preparing, handling, serving or eatingfood, and before feeding a patient;
(v) when hands are visibly soiled(13,20);
(vi) after situations or procedures in whichmicrobial or blood contamination of hands islikely;
(vii) after removing gloves(11,20,74) ; and
(viii) after personal body functions, such as using thetoilet or blowing one’s nose. Category B;Grade II*
2. Hand washing should be encouraged whenever ahealth care provider is in doubt about the necessityfor doing so. Category B; Grade III
6
Table 4. Proposed Strategies to Improve Hand Washing Technique and Compliance
Obstacle Strategy
Lack of knowledge Education with supportive literature, videotaped instructions, hand washingdemonstrations; frequent refreshers; involvement of personnel in education andfeedback(7,8,65)
Feedback on infection rates(64)
Lack of motivation Direct observation and feedback on regular basis(65); role models; involvement ofstaff in studies; application of new technologies(63,66-69)
Programs on hand hygiene for patients and families(64,70)
Availability of hand washing facilities Hand washing facilities conveniently located throughout the health caresetting (67,68)
A sink accessible to personnel in or just outside every room; more than one sinkper room may be necessary if a large room is used for several individuals.
Hand washing facilities in or adjacent to rooms where health care procedures areperformed
Accessible, adequately supplied and proper functioning soap and towel dispensers or hand dryers
Faucets with foot, wrist or knee operated handles; faucets with an electric eye arealso desirable.
Waterless antiseptic agents readily available in wall mounted dispensers, or insmall containers for mobile care such as home care and for emergencyresponders.
Hand washing product Hand washing products that have a high level of acceptability to staff, withappropriateness, cost, supply, etc., being taken into consideration(55,59)
Dermatitis Lotions to prevent skin dryness
Lotion supplied in small, non-refillable containers(43-45,72)
Compatibility between lotion and antiseptic products and effect on glove integrity
Lotions approved by personnel in infection control and occupational health(73)
* See Appendix 2 for the rating system used in these recommendations.
3. As well as between patient/resident/client contacts,hand washing may be indicated more than once inthe care of one person, for example after touchingexcretions or secretions and before going on toanother care activity for the same person(37). Category B; Grade II
4. Superficial contact with an object not suspected ofbeing contaminated, such as when touching orcollecting food trays, generally does not require hand washing. Category B; Grade III
5. Hand washing facilities should be convenientlylocated throughout the health care setting. Theyshould be available in or adjacent to rooms wherehealth care procedures are performed. If a large room is used for several individuals, more than one sinkmay be necessary. Sinks for hand washing should beused only for hand washing and not for any otherpurpose, e.g., as a utility sink. There should be access to adequate supplies and proper functioning soap and towel dispensers or hand dryers, or liberal use ofwaterless hand wash agents(41,68,69). Category B;Grade II
6. To avoid recontaminating hands, faucets with foot,wrist, or knee operated handles should be installedwherever possible; faucets with an electric eye arealso desirable. If automated faucets are not available,single-use towels should be supplied for user to turnoff faucets. Category B; Grade III
7. Hands should be dried thoroughly with either asingle-use towel or electric air dryer (26,27). CategoryA; Grade II
8. Hand lotion may be used to prevent skin damagefrom frequent hand washing(55). Lotion should besupplied in disposable bags in wall containers bysinks or in small, non-refillable containers to avoidproduct contamination. Skin lotions for patientand/or staff use have been the reported source ofoutbreaks (43-45,72,73). Category B; Grade II
9. Compatibility between lotion and antiseptic productsand lotion’s potential effect on glove integrity should be checked(75,76). Category A; Grade II
10. Liquid hand wash products should be stored in closed containers and dispensed from either disposablecontainers or containers that are washed and driedthoroughly before refilling. Category A; Grade II
11. Hand washing with plain soap is indicated in routinehealth care and for washing hands soiled with dirt,blood or other organic material. Plain soap and waterwill remove many transient organisms(20-22,40,59,77).Category A; Grade II
12. Hand washing with an antiseptic agent is indicatedfor the following situations:
(i) when there is heavy microbial soiling, e.g., inthe presence of infection or a high level ofcontamination with organic matter such asinfected wounds and feces(36,47,48,78). CategoryA; Grade II;
(ii) prior to performing invasive procedures (e.g.,the placement and care of intravascularcatheters, indwelling urinary catheters) (2,5,6).Category A; Grade I;
(iii) before contact with patients who have immunedefects, damage to the integumentary system(e.g., wounds, burns), or percutaneousimplanted devices(3,6). Category A; Grade II;
(iv) before and after direct contact with patientswho have antimicrobial-resistantorganisms(32,35,36). Category A; Grade II
13. Hand washing with waterless/alcohol-based agents is equivalent to soap and water, and these agents should be made available where access to water islimited(42,59,78). If there is heavy microbial soiling,hands must first be washed with soap and water toremove visible soiling(20). Hands must be dry beforean alcohol-based agent is used because moisture from wet hands dilutes the alcohol. Category A; Grade II
14. Compliance with hand washing procedures should be encouraged by involving users as much as possible in product selection, facilities design, studies,application of new technologies, education programsand feedback(63,64,69). Category A; Grade II
15. Patients/clients/residents in settings where patienthygiene is poor should have their hands washed.Patients/residents should be helped to wash theirhands before meals, after going to the bathroom,before and after dialysis, and before leaving theirroom. Category B; Grade III
7
F. Glovesi) Glove use
Gloves are worn toa. provide an additional protective barrier between
health care workers’ hands and blood, body fluids,secretions, excretions and mucous membranes(74,79),and
b. reduce the potential transfer of microorganisms frominfected patients to health care workers, and frompatient to patient via health care workers’ hands(81).
Glove use should be an adjunct to, not a substitutionfor, hand washing. If hand washing is performedcarefully and appropriately by all personnel, gloves arenot necessary to prevent transient colonization of healthcare workers' hands and subsequent transmission toothers(82).
In 1987, the Laboratory Centre for Disease Control(LCDC) recommended the use of gloves for specificsituations, primarily to protect the health care workerfrom exposure to bloodborne pathogens(83). Applicationof universal precautions(82-84) significantly increased theuse of gloves in the health care setting. Some institutionsadopted body substance isolation precautions(85), whichexpanded the use of gloves to prevent contamination ofhands.
ii) Selection of gloves
It is important to assess and select the mostappropriate glove to be worn for the circumstances.Selection of gloves should be based on a risk analysis ofthe type of setting, type of procedure, likelihood ofexposure to blood or fluid capable of transmittingpathogens, length of use and amount of stress on theglove(86). Factors such as personal comfort and fit, costand latex allergy in employees and clients/residents arealso important considerations.
iii) Glove types
Non-sterile gloves sold in Canada must meet therequirements of Health Canada Information Letter No.777 (April 30, 1990). Health Canada recommendspurchasing gloves with the Canadian General StandardsBoard certification mark, which ensures that voluntarynational standards are met during manufacturing.However some types of glove materials are not availablein certified brands. The Medical Devices Bureau ofHealth Canada has an information package on glovequality and certification, and on latex allergy (1-800-267-9675)(87).
Studies have demonstrated varying effectiveness ofgloves as barrier protection. Some studies haveconcluded that latex gloves were associated with lessleakage than vinyl gloves(74,88-92). Other studies haveshown non-latex gloves to be effective (79,93-96).
iv) Problems of glove use
Constant use of gloves may cause irritant dermatitis.The cause of the dermatitis may be mechanical irritationfrom the glove or glove powder; it may also be chemicalagents, such as residual soap, trapped between the gloveand skin.
Latex allergy is an increasing concern in health caresettings because of the potentially serious outcomes inworkers and clients who are allergic to latex. Someemployees affected by latex allergy may be able to workin an area where others are using low protein, non-powdered latex gloves. Employees and clients who areseverely allergic to latex need to avoid all contact with it.
For further information on latex allergy in health carefacilities, refer to the Canadian Healthcare Associationpublication Guidelines for the Management of LatexAllergy and Safe Latex Use in Health Care Facilities(97).
Recommendations on Glove Use
For further information and recommendations onglove use, refer to Health Canada’s Infection ControlGuidelines Preventing the Transmission of BloodbornePathogens in Health Care and Public ServicesSettings(84) and the revision of Health Canada’s Isolationand Precaution Techniques(98).
1. Gloves should be used as an additional measure, notas a substitute for hand washing(74,99). Category B:Grade II
2. Gloves are not required for routine patient careactivities if contact is limited to a patient's intact skin, e.g., when transporting patients. Category B;Grade III
3. Gloves may not be needed for routine diaper changes if the procedure can be done without contaminatingthe hands with stool or urine. Category C
4. Clean non-sterile gloves should be worn
(i) if exposure is anticipated to blood and bodyfluids capable of transmitting bloodborneinfection(84),
(ii) if exposure is anticipated to potentiallyinfectious material such as pus, feces,
8
respiratory secretions or exudate of skinlesions(81,85),
(iii) when the health care worker has non-intact skinon his or her hands. Category A; Grade II
5. Sterile gloves must be worn for procedures in whichthe hands or the instruments being handled areentering a sterile body cavity or tissue(2,100).Category A; Grade I
6. The accepted standard should be that medical glovesbe worn for all blood collection procedures.However, if phlebotomists choose not to wear gloves routinely, they must be gloved for perfomingphlebotomy if they have cuts, scratches or otherbreaks in their skin, or when hand contaminationwith blood is anticipated. All students or newtrainees must wear medical gloves during theirtraining period and in subsequent blood collectionprocedures(84).
7. Worn gloves should be changed
(i) between patient/client/resident contacts,
(ii) if a leak is suspected or the glove tears,
(iii) between care activities and procedures on thesame patient after contact with materials thatmay contain high concentrations of micro-organisms (e.g., after manipulating anindwelling urinary catheter and beforesuctioning an endotrachial tube)(74,88).. Category A; Grade II
8. Hands must be washed after gloves areremoved(74,86,89,91). Category A; Grade II
9. Potentially contaminated gloves should be removedprior to touching clean environmental surfaces (e.g.,lamps, blood pressure cuffs)(74,101). Category A;Grade II
10. Single-use disposable gloves should not be washedor reused. Category A; Grade II
11. Disposable, good quality medical gloves made ofvinyl, nitrile, neoprene or polyethylene serve asadequate barriers, particulary when latex allergies are a concern. Category A; Grade II
The Health and Safety Act requires that employersprovide appropriate personal protective apparatus(102). They should make suitable gloves available toemployees to prevent the transmission of infection toresidents/clients/patients. Employees should assessthe risk in each procedure, choose gloves that areappropriate to the task, and recommend alternativegloves if the ones available are not adequate(84,86).The following is suggested as a guide.
(i) If latex gloves are chosen, low protein andunpowdered gloves should be selected.
(ii) Non-latex gloves should be available forindividuals with latex sensitivity.
(iii) Vinyl gloves should be used for short tasks orfor tasks in which there is minimal stress toglove material.
(iv) For housekeeping activities, instrumentcleaning and decontamination procedures,general purpose reusable household gloves(e.g., neoprene, rubber, butyl) are recom-mended. Medical gloves are not durableenough for these activities.
9
Cleaning, Disinfecting and SterilizingPatient Care Equipment*
Appropriate cleaning, disinfection and sterilization ofpatient care equipment are important in limiting thetransmission of organisms related to reusable patient care equipment. Decisions concerning the appropriateprocesses, methods or products are complex, given themany types and compositions of medical devices and thegreat variety and combination of cleaning, disinfectionand sterilization methods available(103-108).
The reprocessing method required for a specific itemwill depend on the item’s intended use, the risk ofinfection to the patient, and the amount of soiling(59,109-111).Cleaning is always essential prior to disinfection orsterilization. An item that has not been cleanedcannot be assuredly disinfected or sterilized. SeeTable 5 for examples.
A. Classification of Medical Devices In the 1970s, E.H. Spaulding developed a system to
classify the cleaning, disinfection and sterilizationrequirements for equipment used in patient/client care.This system divides medical devices, equipment andsurgical materials into three categories based on thepotential risk of infection involved in their use(117). Thethree categories are noncritical, semicritical, and critical.The categories are defined in the glossary at the end ofthis document.
B. Cleaning Equipment and InstrumentsCleaning is an extremely important part of
equipment and instrument reprocessing and is
necessary to permit maximum efficacy of subsequentdisinfection and sterilization treatments.
Effective cleaning can physically remove largenumbers of microorganisms(118). Soil or other foreignmaterials can shield microorganisms and protect themfrom the action of disinfectants or sterilants or interactwith the disinfectant or sterilant to neutralize the activityof the process(119-122). Organic material left on a medicaldevice is extremely difficult to remove after treatmentwith glutaraldehyde, which acts as a fixative.
Manufacturers must provide detailed directions foreffective cleaning of all reusable products. The methodand effectiveness of cleaning an item must be considered prior to purchase. Do not purchase products that cannotbe cleaned. If such products are purchased the health care setting has the responsibility to develop detailed cleaning procedures. Effective reprocessing requires rigorouscompliance with recommended protocols. Even fullcompliance with protocols may be insufficient if themethod or product selected is inadequate or inappropriate for cleaning and subsequent disinfection or sterilizationof a particular device.
Staff responsible for cleaning contaminated healthcare equipment must be properly trained and conversantwith the purpose of their task. They should wear personal protective equipment appropriate to the task to protectthemselves from exposure to potential pathogens andchemicals and to protect the integrity of their skin.Employees should also be immunized against hepatitis B(84).
10
* See Appendix 1 for definitions of the following items: noncritical items, semicritical items, critical items, biofilm, cleaning,decontamination, disinfection, germicides, low level disinfection, intermediate level disinfection, high level disinfection, sanitation,sterilization.
11
Table 5. Reprocessing of Commonly Used Equipment in Health Care Settings in Usual Situations(See the section on Housekeeping for routine environmental cleaning; outbreaks may requirespecial disinfection measures)
MANUFACTURERS’ RECOMMENDATIONS FOR CONCENTRATION AND EXPOSURE TIME MUST BE FOLLOWED.
Process Equipment Examples of items* Products or methods†
Cleaning
Some items mayrequire low leveldisinfection‡
All reusableequipment
All reusable equipment, since suchequipment requires cleaning after use andbefore further disinfection processes areinitiated
Certain environmental surfaces (e.g., ofdental lamps) touched by personnel duringprocedures involving parenteral or mucousmembrane contact
Bedpans, urinals, commodes
Stethoscopes
Blood pressure cuffs
Ear specula
Hemodialysis surfaces in contact withdialysate
Physical removal of soil, dust or foreignmaterial. Chemical, thermal or mechanicalaids may be used.
Cleaning usually involves soap and water,detergents or enzymatic agents.
Quaternary ammonium compounds
Phenolics should not be used in nurseries
Some iodophors
3% hydrogen peroxide
Cleaningfollowed byintermediate level disinfection‡
Somesemicriticalitems
After large environmental blood spills orspills of microbial cultures in the laboratory
Glass thermometers
Electronic thermometers
Hydrotherapy tanks used for patients whoseskin is not intact‡
Alcohols
Hypochlorite solutions
Iodophors
Phenolics should not be used in nurseries.
Cleaningfollowed by highlevel disinfection
Semicriticalitems
Flexible endoscopes‡
Laryngoscopes‡
Respiratory therapy equipmenta‡
Nebulizer cups‡
Anesthesia equipment‡
Endotrachial tubes‡
Nasal specula
Tonometer foot plate‡
Ear syringe nozzles
Vaginal specula
Vaginal probes used in sonographicscanning‡
Pessary and diaphragm fitting rings‡
Cervical caps
Breast pump accessories
Items intended for sterilization in the plasmaor EO sterilizers must be meticulouslycleaned prior to sterilizing(112).
Pasteurization(113)
2% glutaraldehyde
6% hydrogen peroxide
Peracetic acid
Chlorine or chlorine compounds
* For products that appear in two categories, manufacturers’ directions differ for length of exposure time and concentration.† Manufacturers' recommendations for concentration and exposure time must be followed.‡ For guidelines regarding disinfection, refer to comprehensive discussion of disinfection issues(110,114-116).
i) Sorting and soaking
Unless they can be cleaned immediately, instrumentsand small items should be sorted and then submerged inwater and/or detergent to prevent the organic matter from drying on them. Complete disassembly of each item isnecessary to allow effective cleaning. Heavy or nonim-mersible items should be wrapped in or covered with awet towel.
ii) Removal of organic material
Removal is done with the use of detergents, enzymatic cleaners, or elevated temperature with or without the useof mechanical devices such as washer-sterilizer, ultra-sonic cleaner, dishwasher, utensil washer or washer-disinfectors. A detergent is used to reduce surfacetension and suspend the soil in water. The detergentselected must be compatible with the subse quent dis-infection process because some products can interferewith chemical disinfection or sterilization. An enzymaticsolution may be used to help in the removal of protein-
aceous material when plain water and/or a detergentsolution is considered inadequate. Combination low level disinfectant-detergent products (also referred to asgermicidal detergents) are frequently used to clean itemsthat do not require further disinfection or sterilization(e.g., intravenous [IV] poles, commodes, wheelchairs).
iii) Rinsing
A thorough rinsing is necessary to remove all the soiland cleaning agent from the items, to avoid spotting andto ensure thorough cleanliness. Depending upon thequality of the available water supply, the final rinse mayrequire distilled or de-ionized water(119). Cleaning agents(i.e., detergents) may also make surfaces slippery orleave residuals that impair equipment integrity andfunction. When cleaning is to be followed bydisinfection, it must be ensured that residuals of thecleaning agent are removed to prevent neutralization ofthe disinfectant(120,123).
12
Process Equipment Examples of items* Products or methods†
Cleaningfollowed bysterilization
Critical items All items contacting sterile tissue
Surgical instruments
All implantable devices
Needles and syringes
Cardiac and urinary catheters
Hemodialysis, plasmapheresis and heart-lung oxygenator surfaces in contact with blood
All intravascular devices
Biopsy forceps or biopsy equipmentassociated with endoscopy equipment
Bronchoscopes‡
Arthroscopes‡
Laparoscopes‡
Cystoscopes‡
Transfer forceps
Acupuncture needles and body piercingobjects
Neurologic test needles
Arterial pressure transducers‡
High speed dental handpieces
All instruments used for footcare
Steam under pressure
Dry heat
Ethylene oxide gas
2% glutaraldehyde
6-25 % hydrogen peroxide
Peracetic acid
Chlorine dioxide
6-8% formaldehyde
* For products that appear in two categories, manufacturers’ directions differ for length of exposure time and concentration.† Manufacturers' recommendations for concentration and exposure time must be followed.‡ For guidelines regarding disinfection, refer to comprehensive discussion of disinfection issues(110,114-116).
iv) Drying
Drying prevents microbial growth. All items thatrequire no further treatment must be dried prior tostorage. Immediate drying is necessary to preventcorrosion of stainless steel equipment. While they aredrying, the items should be inspected to ensure that theyare free of all organic soil, oil, grease, and othermatter(124). Post-disinfection flushing of endoscopes with70% alcohol to ensure thorough drying prior to storagehas been recommended(118).
Bacteria grow attached to surfaces because of theirhydrophobicity (insolubility in water)(119,125) . Whennonsterile surfaces are moist or continuously wet, theymay become coated with a “biofilm”, which is a layer ofbacteria encased in an extracellular substance. Biofilmand its bacteria can be released when disrupted (e.g., inthe lumens of endoscopes). Biofilm development mayalso protect bacteria from subsequent disinfection orsterilization.
Items that require further disinfection or sterilizationmay also need to be dried, as water may dilute the actionof the chemical disinfectant.
C. DisinfectionDisinfection is required when cleaning processes
alone do not render an item safe for its intended use.There are three major methods of disinfection: liquidchemicals, pasteurization and ultraviolet radiation.Failure to use disinfection products or processesappropriately has repeatedly been associated with thetransmission of nosocomial infections(117,126, 127). Table 5 shows the cleaning and disinfection levels required formany commonly used items of equipment.
In health care settings, the precise nature of themicrobial burden may not be known. In the naturalenvironment, microorganisms are usually found inmixtures. For example, fecal material contains vegetative as well as spore forms of bacteria along with fungi,viruses and protozoa. Therefore, products and procedures selected to disinfect instruments must be known to beeffective against pathogens with varying levels ofresistance (See Figure 1). The level of disinfectionachieved depends on factors such as contact time,temperature, extent of soil, type and concentration of theactive ingredients of the chemical disinfectant, and thenature of the microbial contamination(121,126,128).
A variety of factors influence the efficacy ofdisinfectant processes, including the innate resistance ofthe microorganisms (Figure 1), the concentration andtype of organic and inorganic material present
(cleanliness, presence of biofilm), the intensity andduration of the treatment, the concentration (on initialand repeated use) of the disinfectant, the temperatureassociated with the process, the contact time associatedwith the process, the pH of the solution, the hardness ofwater used as the diluent, and interfering residues thatmay remain after cleaning(126,128, 129).
i) Chemical disinfection
In Canada, chemical disinfectants used in health caresettings are regulated by the Health Protection Branch ofHealth Canada (see the discussion of Registration ofDisinfectants in Canada later in this section).
ii) Relative resistance of microorganisms
Microorganisms have variable susceptibility todisinfectant agents (see Fi gure 1). Vegetative bacteriaand enveloped viruses are usually the most sensitive, and bac ter ial spores and protozoan cysts the most resistant.Some pathogens (e.g., Pseudomonas aeruginosa) havebeen shown to be significantly more resistant thantheir laboratory grown counterparts to a variety ofdisinfect ants in their “naturally occurring” state,(i.e., in body fluids and tissues)(110).
Major classes of disinfectant chemicals and theirrelative advantages and disadvantages are summarized in Table 6. The manufacturer of the chemical disinfectantwill provide instructions for use, including therecommended exposure time. Manufacturers’recommendations regarding exposure time must befollowed.
iii) Creutzfeldt-Jakob Disease (CJD)
The Laboratory Centre for Disease Control isdeveloping CJD protocols(134,135). The prion that causesCreutzfeldt-Jakob resists normal inactivation methods.Human infection with the CJD agent has resulted fromeither direct exposure of the brain to the CJD agent (e.g.,dura mater graft) or peripheral injection of CJD agent-contaminated product derived from human brain(pituitary hormone). Special CJD-specific infectioncontrol precautions are recommended for patients whohave developed, are suspected of having developed, orare at substantially increased risk of developing CJD(i.e., persons who have received human pituitaryhormone [growth hormone and gonadotrophin] or duramater grafts, or members of a family in which CJD isrecognized as being familial)(135).
Needles, needle electrodes, scalpels, ophthalmictonometers, autopsy instruments, dedicated equipmentcryostats and all other potentially contaminated materials should be sterilized by special procedures.
13
Figure 1.Classes of Microorganisms Ranked in Descending Order from Least to Most Susceptible to Chemical Disinfectants
Least susceptible
Most susceptible
BACTERIA WITH SPORES(Bacillus subtilis, Clostridium tetani, C. difficileC. botulinum)
PROTOZOA WITH CYSTS(Giardia lamblia, Cryptosporidium parvum)
MYCOBACTERIA NON-ENVELOPED VIRUSES(Mycobacterium tuberculosis (Coxsackieviruses, polioviruses,M. avium-intracellulare, M. chelonae) rhinoviruses, rotaviruses,
Norwalk virus, hepatitis A virus)
VEGETATIVE BACTERIA(Staphylococcus aureus, Salmonella typhi, Pseudomonas aeruginosa,coliforms)
ENVELOPED VIRUSES(Herpes simplex, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, measles virus, mumps virus, rubella virus, influenzavirus, respiratory syncytial virus, hepatitis B and C viruses,hantaviruses, and human immunodeficiency virus)
FUNGI(Candida species, Cryptococcus species, Aspergillus species, Dermatophytes)
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Table 6. Major Classes of Chemical Disinfectants and their Relative Advantages andDisadvantages
MANUFACTURERS’ RECOMMENDATIONS FOR CONCENTRATION AND EXPOSURE TIME MUST BE FOLLOWED.
Disinfectant Uses Advantages Disadvantages
Alcohols Intermediate level disinfectant
Disinfect thermometers, externalsurfaces of some equipment (e.g.,stethoscopes).
Equipment used for home health care(59)
Used as a skin antiseptic
Fast acting
No residue
Non staining
Volatile
Evaporation may diminishconcentration
Inactivated by organic material
May harden rubber or causedeterioration of glues
Use in the OR is contraindicated
Chlorines(131) Intermediate level disinfectant
Disinfect hydrotherapy tanks, dialysisequipment, cardiopulmonary trainingmanikins, environmental surfaces.
Effective disinfectant following bloodspills; aqueous solutions (5,000 partsper million) used to decontaminate area after blood has been removed; sodiumdichloroisocyanurate powder sprinkleddirectly on blood spills fordecontamination and subsequentcleanup.
Equipment used for home healthcare(59)
See Table 7 for uses for and dilution ofchlorines.
Low cost
Fast acting
Readily available innon hospital settings
Corrosive to metals
Inactivated by organic material
Irritant to skin and mucous membranes
Unstable when diluted to usable state(1:9 parts water)
Use in well-ventilated areas
Shelf life shortens when diluted
Ethylene oxide Used as gas for the sterilization of heatsensitive medical devices
Sterilant for heat orpressure sensitiveequipment
Slow acting and requires several hoursof aeration to remove residue. One ofits carriers (chlorofluorocarbon) is nowa restricted chemical.
Formaldehyde Very limited use as chemisterilant
Sometimes used to reprocesshemodialyzers
Gaseous form used to decontaminatelaboratory safety cabinets
Active in presence oforganic materials
Carcinogenic
Toxic
Strong irritant
Pungent odour
Glutaraldehydes 2% formulations — high leveldisinfection for heat sensitiveequipment
Most commonly used for endoscopes,respiratory therapy equipment andanesthesia equipment
Noncorrosive to metal
Active in presence oforganic material
Compatible withlensed instruments
Sterilization may beaccomplished in 6-10hours
Extremely irritating to skin and mucous membranes
Shelf life shortens when diluted(effective for 14-30 days depending onformulation)
High cost
Monitor concentration in reusablesolutions
Fixative
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Disinfectant Uses Advantages Disadvantages
Hydrogen peroxide
3% — low level disinfectant
Equipment used for home health care(59)
Cleans floors, walls and furnishings
6% — high level disinfectant
Effective for high level disinfection offlexible endoscopes(132)
Foot care equipment
Disinfection of soft contact lenses
Higher concentrations used aschemisterilants in specially designedmachines for decontamination of heatsensitive medical devices
Strong oxidant
Fast acting
Breaks down intowater and oxygen
Can be corrosive to aluminum, copper,brass or zinc
Iodophors Intermediate level disinfectant for some equipment (hydrotherapy tanks,thermometers)
Low level disinfectant for hardsurfaces and equipment that does nottouch mucous membranes (e.g., IVpoles, wheelchairs, beds, call bells)
Rapid action
Relatively free oftoxicity and irritancy
Note: Antiseptic iodophors are NOTsuitable for use as hard surfacedisinfectant
Corrosive to metal unless combinedwith inhibitors
Disinfectant may burn tissue
Inactivated by organic materials
May stain fabrics and syntheticmaterials
Peracetic acid High level disinfectant or sterilant forheat sensitive equipment
Higher concentrations used aschemisterilants in specially designedmachines for decontamination of heatsensitive medical devices
Innocuousdecomposition (water,oxygen, acetic acid,hydrogen peroxide)
Rapid action at lowtemperature
Active in presence oforganic materials
Can be corrosive
Unstable when diluted
Phenolics Low/intermediate level disinfectants
Clean floors, walls and furnishings
Clean hard surfaces and equipment thatdoes not touch mucous membranes(e.g., IV poles, wheelchairs, beds, callbells)
Leaves residual filmon environmentalsurfaces
Commerciallyavailable with addeddetergents to provideone-step cleaning anddisinfecting
Do not use in nurseries
Not recommended for use on foodcontact surfaces
May be absorbed through skin or byrubber
Some synthetic flooring may becomesticky with repetitive use
Quaternaryammoniumcompounds
Low level disinfectant
Clean floors, walls and furnishings
Clean blood spills(133)
Generally non-irritating to hands
Usually have detergent properties
DO NOT use to disinfect instruments
Non-corrosive
Limited use as disinfectant because ofnarrow microbicidal spectrum
iv) Reuse of chemical disinfectants
Several physical and chemical factors influencedisinfectant action, including temperature, pH, relativehumidity, and water hardness(110,128). Extremes of acidityor alkalinity can effectively limit growth of micro-organisms. Moreover, the activity of antimicrobial agents may be profoundly influenced by relatively smallchanges in the pH of the medium(136) . An increase in pHimproves the antimicrobial activity of some disinfectants(e.g., glutaraldehyde, quaternary ammonium compounds) but decreases the antimicrobial activity of others (e.g.,phenols, hypochlorites, iodine). The pH influences theantimicrobial activity by altering the disinfectantmolecule or the cell surface(110).
Many chemical disinfectants require dilution prior touse. It is mandatory that users follow exactly themanufacturer’s directions regarding dilution and mixing.If the concentration of the disinfectant is too low theefficacy will be decreased. If the concentration is toohigh the risk of the chemical damaging the instrument orcausing toxic effects on the user increases.
Once diluted some disinfectants may be used (ifhandled properly) for a period of days or weeks.Dilutions are inherently unstable once mixed and themanufacturer’s directions as to duration of use must befollowed.
Glutaraldehydes require special discussion. Glutar-aldehydes may be in acidic or alkaline formulations, andare usually purchased in concentrated forms and dilutedfor use. These dilutions are time limited. During reuse,the concentration of active ingredient(s) in the productmay drop as dilution of the product occurs (incompletedrying), and while organic impurities accumulate(incomplete cleaning)(128). Chemical test strips areavailable for determining whether an effectiveconcentration of active ingredients (e.g., glutaraldehyde)is present despite repeated use and dilution. Thefrequency of testing should be based on how frequentlythe solutions are used (e.g., used daily, test daily). Thestrips should not be considered a way of extending theuse of a disinfectant solution beyond the expiration date.The glutaraldehyde solution should be considered unsafe
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Table 7. Directions for Preparing and Using Chlorine-based Disinfectants
Product Intended use Recommended dilution Level of available chlorine
Household bleach
(5% sodium hypochloritesolution with 50,000 ppm*
available chlorine)
Cleanup of blood spills Use concentrations rangingfrom 1 part of bleach to bemixed with 99 parts of tapwater (1:100) or one part ofbleach to be mixed with 9parts of tap water (1:10),depending on the amount oforganic material (e.g., blood or mucus) present on the surfaceto be cleaned and disinfected.
0.05% or 500 ppm
0.5% or 5,000 ppm
To add to laundry water One part (one 8 ounce cup) ofbleach to be mixed with about500 parts (28 gal lons†) of tapwa ter
0.01% or 100 ppm
Surface cleaning
Soaking of glassware orplastic items
One part (one 8 ounce cup) tobe mixed with about 50 parts(2.8 gal lons) of tap water
0.1% or 1,000 ppm
NaDCC (Sodium dichloro-isocya nurate) powder with60% avail able chlorine
Cleanup of blood spills Dissolve 8.5 g in one litre oftap water
0.85% or 5,000 ppm
Chloramine-T powder with25% available chlorine
Cleanup of blood spills Dissolve 20 g in one litre oftap water
2.0% or 5,000 ppm
* Parts per million† Imperial gallon (4.5 litres)
For further information on uses of bleach in health care refer to article on subject(131).
when the concentration of glutaraldehyde falls below theminimum effective concentration (MEC) for the productor the dilution falls below 1% glutaraldehyde(110).
v) Disinfectants and safety
Chemical disinfectants are a double-edged sword.Although their use is necessary in many routine healthcare settings, the ability of these products to killinfectious agents also makes them potentially harmful tohumans and the environment. Although manufacturerscontinue to work to improve their formulations, it isunrealistic to expect that highly effective disinfectantsthat are also completely safe will be available in the nearfuture.
Products containing glutaraldehyde require specialattention. Glutaraldehydes are used exten sively in thedisinfection of semicritical instruments because they arenoncorrosive and relatively fast acting in addition topossessing a broad spectrum of activity. However, thepungent and irritating nature of glutaraldehyde fumesand the toxic effects of this disinfectant on skin make it a workplace hazard. The expanding use of glutaraldehydein many health care settings has led to legislation orregulations in some provinces (e.g., British Columbia)that limit workers’ exposure to glutaraldehyde fumes, for instance through the installation of fume hoods andextraction fans in units using glutaraldehyde.
vi) Registration of disinfectants in Canada
In Canada, the main control of antimicrobials rests ontwo pieces of legislation. Antimicrobial products that arelabelled for use in health care facilities or foodprocessing plants or on medical devices and areproduced for the purposes of disease prevention andhealth preservation are regulated as drugs under the Food and Drugs Act and Regulations, which are administeredby the Therapeutic Products Programme, Bureau ofPharmaceutical Assessment, Health Protection Branch,Health Canada. Products used for disinfection orantimicrobial purposes in domestic or householdapplications, non-food industrial applications, etc. areregulated under the Pest Control Products Act andRegulations, which are administered by the PestManagement Regulatory Agency, Health Canada.
For disinfectant drugs, manufacturers must obtain adrug identification number (DIN) from Health Canadaprior to marketing. To obtain this they must submit aDIN application, with labelling and supporting data (ifrequired) to the Therapeutic Products Directorate forevaluation. For a DIN to be issued, it must be established that the product is effective and safe for its intendeduse(137).
The extent of premarket assessment of disinfectantproducts is based on the relative risk associated with theuse of the product, which varies depending on theestablished knowledge of the active ingredients and theproposed uses for the product. On the basis of thispremise, disinfectants or sterilants for use on medicalinstruments undergo a more rigorous pre-marketassessment than disinfectants containing well-knownactive ingredients for use on environmental surfaces such as floors and walls.
Specific efficacy test methodologies and datarequirements for disinfectants to be marketed in Canadaare recommended by the Canadian General StandardsBoard. These requirements vary according to theproposed use(s) of the product, resulting in specific testmethodologies and test organisms to match specificclaims of efficacy. The most stringent requirements existfor sterilants, products that are to be used for thesterilization of critical instruments. High leveldisinfectants carry less stringent requirements and arelabelled for use on semicritical instruments. Low leveldisinfectants are labelled for the disinfection ofnoncritical items and environmental surfaces, and thushave the least stringent efficacy requirements.
The label on the disinfectant must clearly indicate thefollowing information: the product name, a quantitativestatement of active ingredient(s), its intended use, thearea and site of use, and specific directions for use,including the specific types of surfaces/instruments to bedisinfected, any dilution procedure required, the mode of application, the contact time, any cleaning and rinsingprocedures, the temperature for use and the reuse period.The labelling must also include appropriate pre-cautionary symbols and statements as well as first aidinstruction.
The proposed label claims are reviewed, and in orderto be considered acceptable they must have beensubstantiated with data demonstrating with a great levelof confidence that the product is effective under theproposed conditions of use. The label claims must not bemisleading.
Should there be any questions regarding the labelclaims, conditions of use, etc., of a product, thereviewing bureau within the Health Protection Branch(Bureau of Pharmaceutical Assessment) should becontacted for verification. See Appendix 3 forinformation.
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vii) Product labelling
• The product label must have a Drug IdentificationNumber (DIN). The presence of a DIN indicates that,upon review, it has been established that the product is safe and effective for its intended use.
• The prod uct la bel must be read care fully for in struc -tions on use. Fail ure to do so of ten leads to in ap pro -pri ate use, stor age or dis posal of the prod uct and mayex pose the pa tient as well as the health care workerto an in creased risk of in fec tions or toxic chemi cal effects. In ap pro pri ate stor age of chemi cal dis in fec -tants may re duce their shelf life, and if they be comecon tami nated, may also lead to bac te rial growth.
• The product label should include mixing instructions,including concentrations for dilution, and length ofdisinfection time.
• The prod uct label needs to be read for fac tors that may influ ence the activ ity of the dis in fec tant, such as tem -pera ture, pH, rela tive humid ity and water hard ness.
viii) Pasteurization
Pasteurization is a process of hot water disinfection,which is accomplished through the use of automatedpasteurizers or washer disinfectors. Semicritical itemssuitable for pasteurization include equipment forrespiratory therapy and anesthesia.
Exposing respiratory and anesthesia equipment towater above 750 C for 30 minutes is a recognizedalternative to chemical disinfection. Items to bepasteurized must be thoroughly cleaned with detergentand water prior to disinfection(109). The items must betotally immersed in water during the pasteurizationcycle.
The advantages of pasteurization include itsnontoxicity, rapid disinfection cycle, and moderate costof machinery and upkeep.
The major disadvantages of pasteurization are that(1) it is not sporicidal, (2) it may cause splash burns,(3) there is a lack of standardization of the equipmentand (4) there is difficulty validating the effectivenessof the process. The process may be monitored bytemperature gauges and timing mechanisms.
Since pas teuri za tion is not a ster ili za tion pro cess, extreme care must be taken to en sure that the pro cess isap pro pri ately per formed so that in fec tious agents con sid -ered to be par ticu larly im por tant are in ac ti vated(138). Af terpas teuri za tion, spe cial care must be taken to dry (re sid ual wa ter tends to col lect) and pre vent re con tami na tion ofthe equip ment dur ing stor age and trans port(138,139).
ix) Ultraviolet radiation
Microorganisms are inactivated by ultraviolet (UV)light in wavelengths within a range of 250-280 nm(140).Modern mercury-vapor lamps emit radiation within thatlevel. Ultraviolet radiation has several potential appli-cations, but its germicidal effectiveness and use isinfluenced by organic matter, wavelength, type ofsuspension, temperature, type of microorganism, and UV intensity (which is affected by distance and dirty tubes).The application of UV light in the hospital is limited tothe destruction of airborne organisms or inactivation ofmicroorganisms located on surfaces. Ultravioletgermicidal irradiation is a method of air cleaning that can be used to supplement other tuberculosis controlmeasures. Installing ultraviolet lamps in ventilation ducts has two advantages: high levels of UV irradiation may be produced and, since the UV light is in the duct, the riskof human exposure is reduced or eliminated(141). TheHealth Canada Guidelines for Preventing the Trans-mission of Tuberculosis in Canadian Health CareFacilities and Other Institutional Settings(140) concludesits discussion of UV germicidal irradiation by saying that it may be a useful adjunct in ventilation ducts or in high-risk areas, such as bronchoscopy suites, autopsy suites,or other areas where patients with undiagnosed TB maybe seen frequently.
No data support the use of UV lamps in isolationrooms(110). Portable ultraviolet light devices should notbe used for disinfection purposes in community settings(e.g., of esthetic or body piercing equipment).
UV light may cause skin and eye burns, and maytheoretically cause cataracts and skin cancer. Problemshave occurred when UV lights have not been installedproperly or have not been monitored and maintainedcorrectly(139,140).
x) Boiling
Boiling is not an acceptable method of sterilization inhealth care. In home care, boiling has been used todisinfect some items if they do not deteriorate in the pro -cess. Home care guidelines should be followed (59,142,143).
The use of boiling water to clean instruments andutensils cannot be called sterilization. Research hasshown that boiling water or moist heat at a temperatureof 1000 C (2120 F) is inadequate for the destruction ofbacterial spores and some viruses(144). Another majordisadvantage of using boiling water to clean instrumentsand utensils is that the items are not packaged so thatthey can be stored and transported withoutcontamination.
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xi) Sterilization
All critical items that are in contact with the bloodstream, nonintact mucous membranes or normally sterilebody sites must be sterile. Sterilization is a process, notjust a single event. Appropriate procedures must befollowed to achieve and maintain sterility. The sterili-zation process must be validated and documented.
Table 8 summarizes the advantages and disadvantages of sterilization methods as well as recommended appli-cations and monitoring strategies. Manufacturers ofsterilizers should be contacted for specific instructions on installation and use of their equipment. Storage andtransportation practices must maintain sterility to thepoint of use. Manufacturers of sterilizers should bespecific as to which devices can be sterilized in theirmachines, and manufacturers of medical devices andequipment should be specific as to the recommendedsterilization methods.
xii) New technologies
Because of difficulties in disinfecting and sterilizingequipment, such as heat-labile medical devices anddevices with small lumens, new technologies are beingdeveloped. New technologies will have limited appli-cations (e.g., may not be appropriate for instruments with lumens or may be incompatible with some materials). No single method will work for all hospitals. Policies andprocedures must be established to ensure that thereprocessing of equipment follows the principles ofinfection prevention.
There is controversy about the monitoring of theefficacy of liquid chemical sterilization cycles. Biologicmonitoring of liquid chemical sterilization processesusing traditional biologic indicators does not appearfeasible at this time(154).
xiii) Monitoring of the sterilization cycle
Monitoring of sterilization cycles can be divided intothree distinct methods(139):
Mechanical: time and temperature graphs, chartsor printouts
Chemical: time/temperature and/or humiditysensitive tape, strips or pellets(155)
Biologic: spore-laden strips or vials(156)
Mechanical and chemical monitors merely provide avisible indicator that the conditions required to achievesterilization, such as time, temperature and pressure,have been met.
Only biologic indicators monitor the actualeffectiveness of the sterilization process, which isintended to kill all microbes, including spores(157). Anideal biologic indicator should have the followingcharacteristics: a well characterized organism, widelyavailable, standardized preparation, more resistant to thesterilization process than human pathogens, rapidreadout, easy to use, nonpathogenic, and inexpensive(158).
The spores chosen for biologic monitoring must beappropriate for the method of sterilization beingmonitored(154). For example Bacillus stearothermophilusspores are used for steam sterilization and Bacillussubtilis for dry heat and ethylene oxide cycles. Thefrequency of monitoring is indicated in Table 8.
Traditionally, commercially prepared biologicindicators require an incubation time of 24 to 48 hoursprior to reading. The recent development of rapid readout biologic monitors, which use fluorometric detection of aspore-bound enzyme at 60 minutes, may offer analternative to observation of spore growth. Use of rapidreadout biologic indicators may enable release ofsterilized implants for use or rapid recall of inadequatelysterilized devices(156,157). The manufacturer’s instructionsshould be followed in the use of all commerciallyprepared biologic monitoring systems.
Although indicators are an important part of qualityassurance of sterilization processes, the validation of theprocess and documentation of the operating parametersof the process are of paramount importance. Testing with spore and chemical indicators is only as good as theplacement of the spore suspensions or indicators. Allsterilization processes should be thoroughly evaluatedbefore being put into service, and at regular intervalsafterwards. Autoclaves should be mapped withthermocouples to determine potential cold spots. Filtersystems should be tested for leakage. Gas sterilizationunits should be appropriately validated for such factorsas gas concentration, temperature, and relative humidity.
In order to ensure appropriate sterilization processes,health care facility personnel must comply with themanufacturer’s recommendations.
The daily operation of the sterilization must bedocumented by personnel performing the process. Thisdocumentation should be reviewed for each operation,and any malfunction should be noted and appropriateaction taken to ensure that the product either has beenproperly treated or is returned for reprocessing(138).
The health care facility should have a protocol on theprocedure to follow if monitoring shows equipmentfailure(139).
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Table 8. Advantages and Disadvantages of Currently Available Sterilization Methods
MANUFACTURERS’ RECOMMENDATIONS FOR CONCENTRATION AND EXPOSURE TIME MUST BE FOLLOWED.
Sterilization method Parameters Monitoring/frequency Use/advantages Disadvantages
Steam
a) Small table top sterilizers
b) Gravity displacement sterilizers including flashsterilizers
c) High-speed vacuum sterilizers
Flash sterilization
Raised pressure (preset bymanufacturer) to increasetemperature to 1210 C (1330 C for flash sterilizers)
Time varies with temperature,type of material and whether theinstrument is wrapped or not.
Steam must be saturated (narrowlumen items may requireprehumidification).
Flash sterilization should beused only in an emergency.
Flash sterilization should neverbe used for implantable devices.
Air detection for vacuumsterilizers - daily before firstcycle of day
Mechanical - each cycle(103)
Chemical - each cycle(103)
Biologic - at least weekly, butpreferably daily, and with eachload of implantable items(Bacillus stearotherm ophilusspores). Loads containingimplantable devices shall bemonitored and, wheneverpossible, the implantable devicesquarantined until the results ofthe biologic indicator testing areavailable(103).
Mechanical - each cycle
Chemical - each cycle
Biologic - at least once a weekbut preferably daily(145)
Heat tolerant instruments andaccessories
Linen
Inexpensive
Rapid
Efficient
Non toxic
Can be used to sterilize liquids
Not recommended
Unsuitable for anhydrous oils,powders, lensed instruments, heat and moisture sensitive materials.
Some table top sterilizers lack adrying cycle.
If the devices are used before theresults of biologic indicators areknown, personnel must recordwhich devices were used forspecific patients, so that they canbe followed if the load was notprocessed properly(113,145-148).
Difficult to monitor
The efficacy of flash sterilizationwill be impaired if all thenecessary parameters are not metproperly (e.g., time, temper-ature), the device is contaminated with organic matter, air istrapped in or around the device,or the sterilizer or flash pack isnot working properly.
Sterility cannot be maintained ifthe device is not wrapped.
Sterilization method Parameters Monitoring/frequency Use/advantages Disadvantages
Ethylene oxide gas (EtO) EtO concentration based onmanufacturer's recommendation
Temperature - variable
Humidity 50%
Time - extended processing time(several hours)
Mechanical - each cycle(105)
Chemical - each cycle(105)
Biologic - each cycle(105)
(Bacillus subtilis spores)
Heat sensitive items
Not harmful to heat sensitive and lensed instruments
Expensive
EtO systems have been changedbecause of the elimination ofCFCs(149).
Toxic to humans
Environmental hazard whencombined with chlorinatedfluorocarbons
Requires monitoring of residualgas levels in environment
Requires aeration of sterilizedproducts prior to use
Lengthy cycle required toachieve sterilization and aeration
Highly flammable and explosive, and highly reactive with otherchemicals
Causes structural damage tosome devices
Dry heat
a) Gravity convection
b) Mechanical convection
Temperatures - time
1710 C - 60 min
1600 C - 120 min
1490 C - 150 min
1410 C - 180 min
1210 C - 12 hours
Mechanical - each cycle
Chemical - each cycle
Biologic - weekly(139)
(Bacillus subtilis spores)
Anhydrous oil
Powders
Glass
No corrosive or rusting effect oninstruments
Reaches surfaces of instrumentsthat cannot be disassembled
Inexpensive
Lengthy cycle due to slowness of heating and penetration
High temperatures may bedeleterious to material.
Limited packing materials
Temperature and exposure timesvary, depending on article beingsterilized(139).
Glutaraldehyde Time and temperature must bemaintained.
Sterilized items must be rinsedwith sterile water(116,119).
Sterilized items must be handledin a manner that preventscontamination from processthrough storage to use.
None for sterility
Monitors available for pH anddilution concentration
Heat sensitive items Unable to monitor sterilization
Handling provides opportunitiesfor contamination.
Copious rinsing with sterilewater required to remove allresidual disinfectant attermination of cycle.
Toxicity of chemicals to healthcare workers and environment
Lengthy process (6-12 hours).
Sterilization method Parameters Monitoring/frequency Use/advantages Disadvantages
Boiling Not recommended None Not recommended May be used for dedicatedequipment for clients receivinghome care (e.g., catheters used by one person)(59,142,143)
Microwave ovens Not recommended None Not recommended Unable to monitor
Unreliable method(150)
Home use microwaves unable toachieve sterilization(150)
Glass bead sterilizers Not recommended None Not recommended Unable to monitor
Cold spots
Inconsistent heating
Trapped air(151)
Hydrogen peroxide vapour Time and temperature controlledby cycle
Follow manufacturer’s instruc -tions
Spores of Bacillusstearothermophilus are used asbiologic indicators.
Heat sensitive items, e.g.,endoscopes
Noncorrosive due to short contact times required
Environmentally friendlybyproducts
Low toxicity if devices areaerated(152)
Limited field trials on efficacy ofsterilization
Inactivation by highly absorptivematerials such as cellulose paperand linen, thus limitingpackaging material
Inability to enter deeply intosmall lumens(153)
Further evaluation of toxicity isrequired(152).
Hydrogen peroxide
a) liquid (6-25%)
b) gas plasma
Time and temperature controlledby cycle
Follow manufacturer’s instruc tions
Heat sensitive items e.g.,endoscopes
Can be applied to metal and non-metal as well as heat andmoisture sensitive instruments
Rapid
Nontoxic
Lack of corrosion to metals andother materials (except nylon)
Limitations on length and lumens of devices that can be effectivelysterilized (112,153)
With gas plasma, inactivation ofhydrogen peroxide by highlyabsorptive materials (linen,cellulose paper)(153)
Sterilization method Parameters Monitoring/frequency Use/advantages Disadvantages
Peracetic acid Time and temperature controlledby cycle
Follow manufacturer’s instruc tions
Heat sensitive immersible items
e.g., endoscopes, surgicalinstruments
Rapid
Automated
Leaves no residue
Effective in presence of organicmatter
Sporicidal at low temperatures
Monitoring of efficacy ofsterilization cycle with sporestrips is questionable(154)
Can be used for immersibleinstruments only
Corrosive
Material incompatibility withsome materials
Unstable particularly whendiluted
In vapour form, PAA is volatile,has a pungent odour, is toxic, and is a fire and explosion hazard.
Combination systems ofperacetic acid vapour withmixture of hydrogen, oxygen and inert carri er
Time and temperature vary bycycle
Follow manufacturer’sinstructions
Heat sensitive items
Dialysers
Rapid
Nontoxic
Combination system is lesscorrosive than peracetic acidalone
Limited field trials on efficacy of sterilization
Each type of machine needs to be independently verified foreffectiveness
xiv) Maintenace of sterility
a. Packaging
When the process permits, items to be sterilizedshould be packaged in appropriate wraps beforesterilization. One of the main disadvantages of liquidchemical sterilization is that the items are not wrappedbefore sterilization yet must be stored and transported ina way that minimizes contamination. Ideally, the selected packaging material should possess the followingcharacteristics: it should allow for adequate air removal,sterilant penetration and evacuation; act as a barrier tomicroorganisms or their vehicles (e.g., dust, vermin)after sterilization is complete; show temperaturestability; be strong enough to withstand normal handling; be flexible to permit sealing, wrapping and unwrapping;allow for aseptic removal of sterilized product; produceminimal linting; contain no toxic ingredients or non fastdyes; and maintain seal integrity without resealing uponopening. In the case of rigid containers, gasket integritymust be proven(103,105,108).
b. Storage
Sterilized items — those sterilized in the health caresetting and those purchased as sterile — must be storedin a protected area where products are unlikely tobecome exposed to moisture, dirt, dust or vermin. Shelflife is event related(103). Event-related shelf life practicerecognizes that the product should remain sterile untilsome event causes the item to become contaminated(e.g., a tear in packaging, packaging becomes wet, ordropped)(160). Event-related factors include frequency and method of handling, and storage area conditions such asappropriate location, space, open/closed shelving,temperature and humidity, and freedom from dust,insects, flooding, and vermin(138,160).
Items purchased as sterile must be used before theexpiration date if one is given. Culture should be doneonly if clinical circumstances suggest infection related to the use of the item. If intrinsic contamination is sus-pected, notify the Bureau of Radiation and MedicalDevices, Health Protection Branch, Health Canada, andlocal and provincial health departments.
Single-use sterile items that are opened but not usedmay be able to be re-sterilized. However, it is necessaryto ensure that the product can withstand the sterilizationmethod chosen, and that this method will achievesterilization of the device. The Canadian HealthcareAssociation has identified principles for the reuse ofsingle-use medical devices and various activities thatshould be considered in the sterilization procedure(162).
Recommendations on Cleaning, Disinfection andSterilization
Each health care setting should have a protocol forreprocessing and maintenance of sterility.
1. Items that are received sterile must be maintainedsterile until use(139,163,164). Category A; Grade II
2. Reusable items must be thoroughly cleaned beforedisinfection or sterilization(110,120). Category A;Grade II
3. Reusable items must be adequately rinsed and driedbefore disinfection or sterilization(119) and driedbefore storage. Category A; Grade II
4. Manufacturers’ written recommendations for use ofchemical disinfectant should be followed.
5. Only disinfectants with a DIN should be used(disinfectants approved for use in Canada).
6. Respiratory therapy and anesthetic equipment require,at a minimum, high level disinfection(113,165-167).
7. Critical items must be sterile(110) . Category A;Grade III
8. Semicritical items should be disinfected as detailedin Table 5(116,139). Category A; Grade III
9. The sterilization process must be monitored bybiologic indicator testing:
– for steam sterilizers: at least weekly, butpreferably daily. Loads containing implantable devices shall be monitored and, wheneverpossible, the implantable devices quarantined until the results of the biologic indicator testing are available(103).
– for ethylene oxide sterilizers: every load that isto be sterilized(105).
– for dry heat sterilization: at least weekly(139).Category A; Grade III
10. The sterilization process must be monitored at eachcycle by mechanical and chemical indicators(139).Category A; Grade III
11. After reprocessing, sterility should be maintaineduntil point of use(139). Category A; Grade III
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12. If a health care facility reuses a single-use medicaldevice, an established protocol must be establishedand followed to ensure a level of safety, followingthe framework of the Canadian HealthcareAssociation(162).
13. A procedure for recall of items processed from a load that contained a positive biologic indicator should beestablished by the institution(103,105). Category A;Grade III
14. Flash sterilization is not recommended and should be used only in an emergency, and never for implantable devices. Category D; Grade III
15. Microwave ovens, glass bead sterilizers and boilingfor sterilization should not be used (144). Category D;Grade III
16. A specially trained, knowledgable person must beresponsible for the disinfection and sterilizationprocess. Category B; Grade III
26
Microbiologic Sampling of Environment
The results of microbiologic sampling have seldombeen useful in directing infection prevention and controlprograms. Before 1970, routine environmental culturingof inanimate objects was a widely practised infectioncontrol surveillance activity in hospitals. However,nosocomial infection rates have seldom been associatedwith documented colony counts on cultures of air orenvironmental surfaces where reasonable hygiene exists.Meaningful standards for permissible levels of microbialcontamination of the environment do not exist(168). By1988, LCDC strongly recommended that routineculturing of floors, walls, linen, air and infant formula be discontinued(71).
However, microbiologic sampling may be indicated in selected circumstances, such as an outbreak or otherunusual increase in nosocomial infection transmission inwhich environmental reservoirs are implicated. Suchculturing should be based on epidemiologic data andmust follow a written plan that specifies the objects to be sampled and the actions to be taken, based on cultureresults(169).
One major exception to the recommendations to avoid routine spot checking is related to routine sampling of all water and dialysate fluid after dialysis. Gram negativebacteria have the ability to multiply rapidly in water andother fluids associated with the hemodialysis system.These fluids do not need to be sterile, but excessivelevels of gram negative bacterial contamination havebeen associated with numerous pyrogenic andbacteremic reactions(170). A quantitative guideline forinterpretation of levels of contamination has beenproposed(115,170-173).
The issue of microbiologic sampling of hydrotherapypools and tanks is controversial. These tanks have beenassociated with infections. Health care settings that usehydrotherapy pools and tanks may wish to conduct
microbiologic sampling as a quality indicator thatcleaning and water treatment methods are adequate.
Recommendations for Microbiologic Sampling
1. Routine culturing of air, environmental surfaces ormedical devices, either on a scheduled or periodicbasis, is not recommended. Category E; Grade II
2. Routine microbiologic sampling of patient care items purchased as sterile is not recommended. CategoryD; Grade III
3. Routine sampling of the water and dialysate fluidafter dialysis is recommended. Category A; Grade II
(a) Dialysate water used to prepare dialysate fluidshould be checked microbiologically once amonth. The level of contamination should notexceed 200 cfu/mL(174-177).
(b) Endotoxin contamination in dialysate water usedto rinse and reprocess dialysers, and water usedto prepare dialyser disinfectant should notexceed 1 ng (5 endotoxin units [EU])/mL(178,179).
(c) Dialysate fluid should be sampled once a monthat the end of the dialysis treatment. The level ofbacterial contamination should not exceed 2,000cfu/mL. Machine water should be taken fromdifferent machines to ensure randomsampling(174-177).
4. In an outbreak, selective environmentalmicrobiologic sampling may be indicated. Samplingshould be obtained from the potential environmentalsites implicated in the epidemiologic investigation, as suggested by the outbreak organism(s) or patient
27
characteristics, (e.g., when clusters of infectionsoccur in patients following endoscopy procedureswith possible implication of the equipment, thenendoscopes should be sampled) (119). Category A;Grade II
5. If contamination of a commercial product sold assterile is suspected, infection control personnelshould be notified, suspect lot numbers should berecorded, and items from suspected lots should be
segregated and quarantined. Appropriatemicrobiologic assays may be considered. TheMedical Devices Bureau, Environmental HealthDirectorate, Health Protection Branch, HealthCanada, provincial health authorities, andmanufacturers should be notified promptly.Category A; Grade III
28
Housekeeping*
Although microorganisms are ubiquitous in healthcare settings, inanimate materials are seldom responsiblefor the direct spread of infections. Cleaning andmaintenance prevent the build-up of soil, dust or otherforeign material that can harbour pathogens and supporttheir growth(180). Although there is virtually no risk oftransmitting infectious agents to patients by way of theinanimate environment, soiled items could contribute tosecondary transmission by contaminating hands of health care workers or by contact with medical equipment thatwill subsequently come in contact with patients.
Skin antiseptics, except alcohol, should not be usedfor cleaning inanimate objects.
Cleaning is accomplished with water, detergents andmechanical action. Cleaning reduces or eliminates thereservoirs of potential pathogenic organisms.
Detergents are adequate for most housekeeping(59).Disinfectants are not usually needed in housekeepingactivities in health care settings, but are necessary inspecified areas (e.g., surgical suites, ICUs, transplantunits, surfaces of dialysis machines). Refer to Table 9 for indications on the use of a disinfectant. Disinfection isaccomplished by liquid or powdered chemicals. Levels ofchemical disinfection vary with the type of product used(128).
A. Routine CleaningThe aim of cleaning is to achieve a clean environment
with regular and conscientious general housekeeping.Extraordinary measures do not need to be taken todisinfect the health care environment(115); high leveldisinfection and sterilization are not used in house-keeping activities. Visible dust and dirt should be removed
routinely with water and detergent and/or vacuuming(181). Duct, fan and air conditioning systems should be cleaned and maintained according to a schedule.
The environment should be kept free of clutter tofacilitate housekeeping.
The most frequent source of infection from theinanimate environment is contaminated equipment.Decontamination of patient care equipment is discussedon pages 10-26.
However, environmental water reservoirs have beenassociated with numerous infections and outbreaks.Examples include faucet aerators, shower heads, sinks,drains, flower vase water, ice machines, water carafesand hydrotherapy baths(115,173). Housekeeping protocolsshould include careful cleaning of wet surfaces andequipment to prevent the build-up of biofilms.
Hands play a major role in the transmission of humanpathogenic microorganisms to susceptible hosts. Handscan acquire known or potential pathogens by contactwith objects and animate and inanimate surfaces.Strict adherence to hand washing recommendations(see pages 6-7) is more likely to prevent infectionsthan procedures exceeding routine cleaning of theenvironment.
Housekeeping issues concerning the inanimateenvironment and the transmission of disease may besummarized as follows:
Prevent objects heavily contaminated with organicmaterial from coming into close contact with portals ofentry into the body. For example, patients with non-intact skin, such as those with burns or surgical incisions,
29
*See Appendix 1 for definitions of the following terms: antiseptics, cleaning, disinfection, fomites, sanitation.
would be susceptible to infection if exposed to patientcare equipment contaminated with feces. Ensurecontaminated environmental surfaces are clean to preventthe hands of health care workers or patients/residents/clients from becoming contaminated(25).
Ensure that contaminated inanimate environments donot contaminate patients/clients/residents through contact with mucous membranes. The transmission of viral andother infections can be reduced by effective cleaning ofenvironmental surfaces(101). During casual contact,transfer of infectious agents from contaminated surfacesto clean surfaces can readily occur (101), and uponinoculation (contaminated hands touching eyes, mouth,other mucous membranes, etc.) could lead to trans-mission(182). For example, volunteers in a study infectedthemselves with respiratory syncytial virus (RSV) after
handling objects from the room of an RSV-infectedpatient and then touching their noses and mouths(115).
Many human pathogens can remain viable on porousand nonporous inanimate objects from several hours toseveral days(25,129). Laboratory-based investigations haveclearly demonstrated that the spread of many types ofinfectious agents can be successfully interrupted by theirproper cleaning and, when necessary, disinfection(101).
The frequency of cleaning and disinfecting the healthcare environment may vary according to the type ofsurface to be cleaned, the number of people and amountof activity in the area, the risk to patients and the amountof soiling. Horizontal surfaces have a higher number oforganisms than vertical surfaces, ceilings and smoothintact walls.
30
Table 9. Cleaning Procedures for Common Items
Frequency of cleaning will depend on care setting. In acute care settings equipment should be cleaned between patients. In community settings the frequency of cleaning has not been determined.
Surface/object Procedure Special considerations
Horizontal surfaces such as over bedtables, work counters, baby weigh scales,beds, cribs, mattresses, bedrails, call bells
1. Thorough regular cleaning
2. Cleaning when soiled
3. Cleaning between patients/clients andafter discharge
Special procedures sometimes calledcarbolizing are not necessary.
Some environmental surfaces mayrequire low level disinfection (e.g., innurseries, pediatric settings, critical care,burn units, emergency rooms, operatingrooms and bone marrow transplantationfacilities).
Walls, blinds, curtains Should be cleaned regularly with adetergent and as splashes/visible soil occur.
Floors 1. Thorough regular cleaning
2. Cleaning when soiled
3. Cleaning between patients/clients and after discharge.
Damp mopping preferred
Detergent is adequate in most areas.
Blood/body fluid spills should be cleaned up with disposable cloths followed bydisinfection with a low level disinfectant.
Carpets/upholstery Should be vacuumed regularly andshampooed as necessary.
Toys Should be regularly cleaned, disinfectedwith a low level disinfectant, thoroughlyrinsed, and dried (between patients inacute care setting).
For pediatric settings, toys should beconstructed of smooth, nonporous (i.e.,not plush) materials to facilitate cleaningand decontamination.
Do not use phenolics.
Toilets and commodes 1. Thorough regular cleaning
2. Cleaning when soiled
3. Clean between patients/clients and after discharge.
Use a low level disinfectant.
These may be the source of entericpathogens such as C. difficile andShigella(173).
For noncritical devices that have contact only withintact skin (e.g., beds, handrails, IV poles, wheelchairs)and for most large environmental surfaces with whichhumans have little direct contact (e.g., floors, walls,furnishings) routine cleaning is sufficient (Table 9)(139) .This can usually be achieved with water and a detergent.
Some environmental surfaces that are frequentlytouched by health care providers and/or patients, such ascall bell lights, surfaces of medical equipment andknobs/handles for adjustment or opening, have greaterpotential as vehicles for infectious agents. Therefore,careful attention should be paid to the regular cleaning of environmental surfaces that are frequently touched.
For further information on cleaning after the discharge of a patient for whom Contact Precautions have beennecessary, refer to Health Canada's Revision of Isolationand Precaution Techniques(98).
Recommendations for Routine Housekeeping
1. Routine cleaning of environmental surfaces andnoncritical patient care items should be performedaccording to a predetermined schedule and should be sufficient to keep surfaces clean and dustfree(115,180,183). Surfaces that are frequently touched by the hands of health care providers and clients, such as call bells, surfaces of medical equipment and knobsfor adjustment or opening, require frequent cleaning.Category B; Grade III
2. Careful mechanical cleaning of environmentalsurfaces is effective in removing many contaminantsfrom surfaces. Category A; Grade II
3. Health care facilities should determine a schedule for cleaning and maintaining ducts, fans, and airconditioning systems(115). Category A; Grade II
4. An education program for housekeeping staff shouldhelp them to understand the effective methods ofcleaning and the importance of their work. CategoryB; Grade III
5. Damp rather than dry dusting or sweeping should beperformed whenever possible. Any dry cleaningshould be done carefully with a chemically treateddry mop or vacuum cleaner (equipped with exhaustfilter) rather than a broom. Category B; Grade III
6. Vacuum cleaners should be used on carpeted areas.Expelled air from vacuum cleaners should bediffused so that it does not aerosolize dust fromuncleaned surfaces. Category B; Grade III
7. During wet cleaning, cleaning solutions and the tools with which they are applied soon become contamin-ated. Therefore, a routine should be adopted that does not redistribute microorganisms. This may be accom-plished by cleaning less heavily contaminated areasfirst and changing cleaning solutions and cloths/mops frequently. Category B; Grade III
8. Wet mopping is most commonly done with a double-bucket technique, which extends the life of thesolution because fewer changes are required. When asingle bucket is used, the solution must be changedmore frequently because of increased bioload.Category B; Grade III
9. Tools used for cleaning and disinfecting must becleaned and dried between uses. Category B;Grade III
10. Mop heads should be laundered daily in areas ofgreat activity and at a set interval for areas of lessercontamination. All washed mop heads must be driedthoroughly before storage(115). Category B;Grade III
11. Cleaning agents: a detergent is acceptable forsurface cleaning in most areas (Table 9). A low orintermediate grade disinfectant, often called agermicidal detergent(128) (see Tables 6 and 7 forexamples), may be preferable for cleaning innurseries, pediatric settings, critical care, burn units,emergency rooms, operating rooms, bone marrowtransplantation facilities, and surfaces of dialysismachines. Category B; Grade III
12. Phenolics should not be used in nurseries (SeeTables 6 and 7). Category A; Grade II
13. Cleaning and disinfecting agents must be mixed andused according to manufacturers’ recommendations.Category A; Grade III
14. Protective apparatus: household utility gloves shouldbe worn during cleaning and disinfecting procedures. Manufacturers’ directions should be followed forproduct use to ensure safe handling practices.Category B; Grade III
15. Disinfectant fogging should not be done(184).Category D; Grade III
16. Health care facilities should develop policies forcleaning schedules and methods, which shouldinclude the name of the person who is responsible for housekeeping. Category A; Grade III
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B. Special Cleaningi) Special organisms of epidemiologic significance
Except during outbreaks, no special environmentalcleaning techniques are advocated for organisms suchas Clostridium difficile, methicillin-resistant Staphylo-coccus aureus or vancomycin-resistant enterococci(115,185).During an outbreak, thorough environmental cleaningand disinfection with a disinfectant that has demonstrated effectiveness against the specific organism may berequired(186,187).
ii) Blood spills(84)
Note: Some recommendations are not graded forstrength of evidence because they are from previousInfection Control Guidelines, which were not graded.
Recommendations for Cleaning Blood Spills
1. Appropriate personal protective equipment should be worn for cleaning up a blood spill. Gloves should beworn during the cleaning and disinfecting pro-cedures. If the possibility of splashing exists, theworker should wear a face shield and gown. For large blood spills, overalls, gowns or aprons as well asboots or protective shoe covers should be worn.Personal protective equipment should be changed iftorn or soiled, and always removed before leaving the location of the spill, then hands washed.
2. The blood spill area must be cleaned of obviousorganic material before applying a disinfectant, ashypochlorites and other disinfectants are substantiallyinactivated by blood and other materials(84,109,117).
3. Excess blood and fluid capable of transmittinginfection should be removed with disposable towels.Discard the towels in a plastic-lined waste receptacle.
4. After cleaning, the area should be disinfected with alow level chemical disinfectant (e.g., chemicalgermicides approved for use as “hospital dis-infectants”, such as quaternary ammoniumcompounds) or sodium hypochlorite (householdbleach). Concentrations ranging from approximately500 ppm (1:100 dilution of household bleach)sodium hypochlorite to 5000 ppm (1:10 dilution ofhousehold bleach) are effective, depending on theamount of organic material (e.g., blood or mucus)present on the surface to be cleaned and disinfected.See Table 7 for directions on the preparation and useof chlorine-based disinfectants. Commerciallyavailable chemical disinfectants may be morecompatible with certain medical devices that might
be corroded by repeated exposure to sodiumhypochlorite, especially the 1:10 dilution(59,109,133).Manufacturers' recommendations for dilutions andtemperatures of chemical disinfectants approved foruse as hospital disinfectants must be followed.
5. For carpet or upholstered surfaces a low leveldisinfectant may be used. For home health care, acommon supermarket disinfectant may be used.
6. Previous recommendations have suggested thatsodium hypochlorite or chemical germicide shouldbe left on the surface for 10 minutes.
7. The treated area should then be wiped with papertowels soaked in tap water. Allow the area to dry.
8. The towels should be discarded in a plastic linedwaste receptacle.
9. Care must be taken to avoid splashing or generatingaerosols during the clean up.
10. Hands must be thoroughly washed after gloves areremoved.
11. For blood spills in clinical, public health or researchlaboratories, refer to recommendations forlaboratories(188,189).
iii) Surgical settings (modified from Association ofOperating Room Nurses(190-192))
Recommendations for Cleaning Surgical Settings
For the purposes of this discussion, surgical settingsinclude the operating room, ambulatory surgicalunits(148), physicians' offices where invasive proceduresare done, intravascular catheterization laboratories,endoscopy rooms and all other areas where invasiveprocedures may be performed.
1. Cleaning procedures should be completed on ascheduled basis, usually daily.
2. Areas outside the sterile field contaminated byorganic debris should be cleaned as spills or splashesoccur.
3. Surgical lights and horizontal surfaces, equipment,furniture and patient transport vehicles should becleaned between patients with a clean cloth and a low level disinfectant.
4. Floors should be cleaned with a low leveldisinfectant/detergent, preferably using a wet vacuum
32
system between patients(139) or, depending on type ofprocedures carried out, at the end of the day.
5. Counter tops and surfaces that have beencontaminated with blood or body fluids capable oftransmitting infection should be cleaned withdisposable towelling, using an appropriate cleaningagent and water as necessary, (e.g., after eachprocedure, after treatment of each patient/client, atthe completion of daily work activities, and after anyspill). Surfaces should then be disinfected with alow-level chemical disinfectant or sodiumhypochlorite. Loose or cracked work surfaces shouldbe replaced(84).
6. All other areas and equipment in the surgical practice setting, (e.g., air conditioning grills and/or filters,cabinets, shelves, walls, ceilings, lounges and lockerrooms) should be cleaned according to an established routine.
7. Before any piece of portable equipment enters orleaves the operating room, it should be wiped withthe approved disinfectant.
33
Laundry
The potential for transmission of infection from soiled linen is negligible(115,172,193-195). In fact, there are only ahandful of reports suggesting soiled linen as a cause ofcross infection. In these studies, there were suspectedsources of infection other than the soiled linen(115,172,193).When appropriate precautions are followed by caregivers and laundry workers for collecting, transporting,handling, washing, and drying soiled linen, the risk ofcross infection can be virtually eliminated(172,193).
All linen that is soiled with blood, body fluids,secretions or excretions or contaminated with lice orscabies should be handled using the same precautions,regardless of source or care setting(40,115,172,193,196-201). Ifthe bag soaks through, an additional outer bag should beused. Recent studies show that the practice of “doublebagging” linen from isolation areas or when contam-ination with certain bacteria or viruses is suspected is not only costly but also unnecessary(172,193,195,202) .
Microbial counts on soiled linens are significantlyreduced during the mechanical action and dilution ofwashing and rinsing. With the high cost of energy anduse of cold water detergents (which do not require heatto catalyze their actions) hot water washes (>71.1º C for25 minutes) may not be necessary. Several studies showthat low temperature laundering will effectivelyeliminate residual bacteria to a level comparable withhigh temper ature laundering(172,193,195). When lowtemperature washes are combined with the addi tion ofbleach (with a total available residual chlorine of 50-150ppm), residual bacteria on laundry are re duced to belowlevels found on laundry washed at high tempera-tures(172,193). See Table 7 for directions on preparing andusing chlorine-based disinfectants. Machine drying oflinen contributes to a further reduction of residualbacteria(172,193).
Easily laundered clothing should be provided forresidents in group facilities or long-term care facilities toavoid the use of garments (e.g., of silk or wool) requiring dry cleaning or other special handling.
The presence of sharps in soiled linens has causedsharps injuries in laundry workers. A needle trackingsystem may be effective in reducing the number ofsharps found in soiled laundry. This approach establishes a system of feedback to personnel deemed responsiblefor the sharps debris.
Recommendations for Laundry
1. Collection and handling
a. All soiled linen from health care facilities should behandled in the same way for all patients. Category A;Grade II
b. Linen from persons with a diagnosis of rare viral,hemorrhagic fevers (e.g., Lassa, Ebola, Marburg)requires special handling. For detailed handlinginstruc tions refer to Health Canada's CanadianContingency Plan for Viral Haemorrhagic Feversand Other Related Diseases and, from the Centersfor Disease Control and Prevention, Management ofPatients with Suspected Viral HemorrhagicFevers(203,204) . Category B; Grade III
c. Linen should be handled with a minimum ofagitation and shaking(172,193,205). Category B; Grade III
d. Sorting and rinsing of linen should not occur inpatient care areas, except in facilities that use colour-coded, compartmented soiled linen bag carts intowhich different types of linen are sorted, e.g.,
34
personal clothing, towels, reusable incontinenceproducts, bedding. Category B; Grade III
e. In community or home settings where clothes andlinens are not often soiled with blood or body fluids,sorting of linen may take place in care areas(193).Category B; Grade III
f. Heavily soiled linen should be rolled or folded tocontain the heaviest soil in the center of thebundle(172,193). Large amounts of solid soil, feces orblood clots should be removed from linen with agloved hand and toilet tissue and placed into a bedpan or toilet for flushing. Excrement should not beremoved by spraying with water (e.g., from clothing,reusable incontinence pads). Category B; Grade III
2. Bagging and containment
a. Soiled linen should be bagged at the site ofcollection(172,193,206). Category C; Grade III
b. To prevent contamination or soaking through, asingle, leakproof bag (172,195,206) or a single cloth bagcan be used(205). The only indication for a secondouter bag is to contain a leaking innerbag(172,193,195,202) . Category B; Grade II
c. Use of water soluble bags is not recommended asthese require hot water washes that may cause stainsto set. Water soluble bags offer no benefit from aninfection control per spec tive and needlessly add tocosts(172,193). Category B; Grade III
d. Laundry carts or hampers used to collect or transportsoiled linen need not be covered(193). The practice ofplacing lids on soiled linen carts is not necessaryfrom an infection control perspective(193). CategoryB; Grade III
e. Bags should be tied securely and not over-fllledwhen transported either by chute or cart(172).Category B; Grade III
f. Linen bags should be washed after each use and canbe washed in the same cycle as the linen contained in them(193). Category B; Grade III
3. Transport
a. When a laundry chute is used, all soiled linen mustbe securely bagged and tightly closed. There havebeen reports of bacteria-laden air being exhaustedupwards through these chutes; however, infectionshave not been associated with chutes(172,193). The
chute should discharge into the soiled linencollection area. Laundry chutes should be cleaned ona regular basis with a diluted germicide compatiblewith the washing process(206) . Category B; Grade III
b. When linens are commercially laundered, adequateseparation of clean and dirty laundry in the truck isessential to ensure that there is no opportunity formixing clean and dirty linens. Category B; Grade III
c. Linen transported by cart should be moved in such away that the risk of cross contamina tion ismini mized. There is no need to cover carts, althoughodour control may be a fac tor(115,193). Category B;Grade III
d. Separate carts should be used for dirty and cleanlinens. Carts used to transport soiled linens should be cleaned with the cleaning product used in the healthcare setting after each use. Category B; Grade III
e. Clean linen should be transported and stored in amanner that prevents its contamination and ensuresits cleanliness(115,193,207). Category B; Grade III
4. Washing and drying
a. If low temperature water is used for laundry cycles,chemicals suitable for low temperature washing atthe appropriate concentration should be used.Category B; Grade III
b. High temperature washes (> 71.1º C) are necessary if cold water detergents are not used(193). Category B;Grade III
c. To achieve a level of at least 100 ppm of residualchlorine with household bleach, 2 mL of householdbleach should be added for every litre of water. SeeTable 7 for Directions for Preparing and UsingChlorine-based Disinfectants. Category B; Grade III
d. In institutional laundry areas, addition of a mildacidic “souring” agent neutralizes the alkalin ity fromthe fabric, water and detergent. This shift in pH fromapproximately 12 to 5 may inactivate any remainingbacteria and reduce the potential for skinirritation(193). Category B; Grade III
e. Use of a commercial laundry detergent withhousehold bleach (according to product instructionsand where suitable for fabrics) and a normal machine wash and machine dry are sufficient to clean soiledlinen in a community living or home caresetting(40,196-201). Category B; Grade III
35
f. Machine drying or hanging clothing and linens on aclothes line at the home care site is a suitable method for drying. Category B; Grade III
5. Dry cleaning
Clothing containing blood, body fluids or excrementthat is sent to community dry cleaners should beappropriately labelled. Dry cleaning personnel should beknowledgeable of procedures to handle soiled clothingitems.
6. Sterile linen
Only surgical gowns and linens used in sterileprocedures should be sterilized(193,207). Such linens should be steam sterilized following the normal washing anddrying cycle to kill any residual spores. Resterilization of previously sterilized linen requires laundering torehydrate it. Disposable items for use in sterileprocedures may be more cost-effective in somesituations. The need for sterilizing linens for nurseriesand other areas has not been substantiated(193).
7. Protection of laundry workers
a. Workers should protect themselves from potentialcross infection from soiled linen by wearingappropri ate protective equipment, such as glovesand gowns or aprons, when handling soiledlinens(193,205-207). Reusable gloves should be washedafter use, allowed to hang dry, and discarded ifpunctured or torn. Category B; Grade III
b. Hand washing facilities should be readily available.Category B, Grade II
c. Personnel should wash their hands whenever glovesare changed or removed(84).Category B; Grade II
d. Staff in care areas need to be aware of sharps whenplacing soiled linen in bags. Workers are at risk from contaminated sharps, instruments or broken glass that may be contained with linen in the laundrybags(172,193).
e. All care givers and laundry workers should be trained in procedures for handling of soiled linen(193).Category B; Grade III
f. Laundry workers, as other health care workers,should be offered immunization against hepatitis B.
36
Waste Management*
The management of waste generated in health caresettings has been the subject of much debate in recentyears because
• there is a public perception of a higher infection riskfrom medical as compared with household waste,despite evidence to the contrary;
• environmental concerns have limited the use ofincinerator or landfill as a final waste disposal site;
• health care fiscal restraint means that wastemanagement procedures must be based on evidence of risk to workers or the public as well as of decreasedrisk as a result of the procedures.
The waste management guidelines recommended inthis document will be based on the principles of diseasetransmission and esthetic concerns(114,208-209). Themanagement of waste described in this section willreflect the current understanding of disease transmissionand risk, and incorporate an adaptation of the biomedical waste guidelines prepared by the Canadian StandardsAssociation(210-211). Because waste disposal now occursin many diverse health care settings these guidelines willserve as a reference for both institutional and community health care providers.
The categories of human biomedical waste generatedin health care are anatomic, microbiologic/laboratory,blood/body fluid, sharps and isolation waste.
Biomedical waste is not necessarily infectious. Wastedocumented to be associated with risk of diseasetransmission are sharps contaminated with blood; as
well, aerosolization of the tubercle bacillus from medical waste has been reported(212). The ability of other wasteto cause disease depends upon the virulence of themicroorganism, susceptibility of the host, and a portalof entry. Because there are no objective methods todetermine infection risk from waste, it has becomecommonplace to regulate waste when it is suspected ofcontaining pathogens capable of producing disease. Thispractice is not supported by evidence of risk from wasteor of decreased disease transmission associated withthese practices(114,208,209).
A. Public Health RiskWaste generated in health care settings is no more
hazardous than household waste. Data demonstrate thathousehold waste contains 100 times more pathogenicorganisms than medical waste(213).
There is no evidence that any member of the publichas acquired disease from infectious waste(114,208-209, 214).All reports (except one(212)) of disease transmission frombiomedical waste have been a result of occupationalexposure to contaminated sharps in the health caresetting. Laboratory workers have unique exposure risksand have incurred exposures that have resulted intransmission of bloodborne pathogens(84). As out-of-hospital care increases, so will the number of sharpsdisposed of by health care workers in the community(148,215)
(refer to Table 10). At present, needles may be disposedof in the household waste stream by recreational drugusers or persons requiring home health care(59).Accidental needlestick injuries have been reported in10% of waste industry workers over one year because ofimproper disposal of needles in residential waste(217). In
37
*See Appendix 1 for definitions of the following terms: biomedical waste, infectious waste.
Table 10. Recommendations for Management of Untreated Infectious Waste
Waste category* Examples Colour coding packaging† Handling disposal‡ Special considerations
Anatomic waste Tissues
Organs
Body parts
Sealed impervious
containers
Incineration, crematorium For religious or ethical reasonsanatomic waste may be buried in acemetery.
Microbiologic waste Diagnostic specimens
Laboratory cultures
Vaccines
Incineration
Autoclavable bags and plasticwaste holding bags for generalwaste
Incineration or decontaminationby autoclave for landfill(211)
Blood/body fluid waste Phlebotomy bottles
Drainage collection units
Suction containers with blood
Placentas from home deliveries
Sealed impervious containers Sanitary sewer if permitted bylocal regulatory authorities orincineration
Other waste Gloves
Sponges
Dressings
Surgical drapes soiled or soaked
with blood or secretions
Impervious waste holding bags ordouble bag
Landfill It is inappropriate to specify aminimum thickness of plastic bagas plastic materials varyextensively in their physical andmechanical properties.
Sharps Needles
Blood syringes
Lancets
Clinical glass
Puncture resistant sharpscontainers
Incineration or landfill disposal(home health care)
For health care provided in thehome use a puncture-resistantcontainer. Glass containers shouldnot be used. The lid should besecured before disposal intohousehold waste. The localmunicipality or public healthdepartment should be contactedbefore disposal(59,148,210,215)
Isolation waste Lassa fever
Marburg virus disease
Ebola virus disease
Transport Canada approved,sealed, impervious container
Incineration Contact the local public healthauthority(216).
* As per definitions† Biohazard symbol is required on all packaging for incineration; colour coding varies provincially and regionally.‡ All transportation of infectious waste must comply with the Transportation of Dangerous Goods Act, Transport Canada(216).
Canada, tracking methods for community-acquiredneedlestick injuries, both in health care workers and nonhealth workers such as waste industry workers, requirefurther development(218).
Esthetics plays a role in the management ofbiomedical waste. The waste generated during healthcare delivery is perceived by the public to pose a threatto health. However, the public perception of hazard doesnot equate with the actual risk of contracting infectiousdiseases(213,219,220).
Blood-soaked waste has also received much attention.Increased public concern over bloodborne pathogens hasresulted in the erroneous extension of bloodbornepathogen precautions to treat all blood/body fluid wasteas potentially infectious. Items soaked or dripping withblood, contained in an impervious plastic bag beforebeing sent to the landfill, pose no threat to the publichealth. Special treatment (e.g., incineration) of bloodsoaked waste is not required, and has enormous cost andenvironmental implications(59,211,221,222).
Sharps contaminated with body fluid(84) and untreatedmicrobiologic waste(188) require special handling andtreatment. Sharps must be contained in a puncture-proofcontainer. Sharps and microbiologic waste should beincinerated prior to disposal. Local environmental andhealth regulatory authorities should be consulted whenimplementing the waste treatment and disposalrecommended in this document.
B. Treatment of WasteThe treatment of infectious waste to render it non-
infectious, in some instances, may be stipulated by localregulatory authorities. The principles of appropriatetreatment methods follow.
i) Chemical decontamination
Chemical decontamination of infectious fluids isgenerally not indicated except for the cleanup of bloodspills(84). Chemical treatment of sharps, such as adding adisinfectant to a sharps container, does not render sharpssafe for further handling.
ii) Steam sterilization
Steam sterilization is most often used fordecontamination of microbiologic waste before finaldisposal in a landfill(188). Steam autoclaving is anappropriate method of treating microbiology laboratorywaste(189), blood and body fluid waste (if applicable), and
non-anatomic animal wastes. It must not be used fortreating anatomic waste(210). The penetration of steaminto the waste is essential for decontamination, andtherefore the packaging of waste, and the volume andloading of the autoclave are crucial. Biologic monitoringshould be used to confirm that a routine cycle achievessterilization(210).
C. Disposal Methods for WasteThere are three common methods of waste disposal
for biologic waste in Canada, which may vary inavailability according to location.
i) Landfill
It is acceptable to dispose of specific categories ofwaste in a properly managed landfill provided there areprocedures in place to protect workers from contact withthe waste. Studies have shown that bacteria and virusesin a landfill are significantly reduced in number byprocesses such as thermal inactivation and adsorption oforganic material in the solid waste. The leachatesimilarly contains relatively low concentrations ofpathogenic organisms and therefore poses minimal riskto the surrounding environment(214). It is, however, anoverall environmental goal to reduce waste of all types,including waste for disposal into the landfill. The landfill disposal method is inexpensive when compared withincineration(220). Local regulations must be followed.
ii) Sanitary sewer
The sanitary sewer is an acceptable method ofdisposal of blood, suctioned fluids, excretions andsecretions(210) . The disposal of such liquids into sanitarysewers must conform to municipal sewerage by-laws and provincial regulations and legislation(211).
iii) Incineration
Incineration is the process that converts combustiblematerials into noncombustible ash, achieving a reduction of 90% by volume or 75% by weight. The product gasesare vented into the atmosphere, and the treatment residue may be disposed of in a landfill. Provincial and territorial regulatory authorities issue requirements for manyaspects of incinerator operation and emissions(210).
D. Safety for Waste HandlersPersons handling infectious waste are at potential risk
of exposure to pathogens from sharps or infectious waste leaking from containers.
39
Recommendations for Waste Management
1. Local environmental and health regulations should be followed when planning and implementing treatmentand disposal policies for biologic waste. Category B; Grade III
2. Specific categories of biologic waste may bedisposed of in a properly managed landfill providedthat there are procedures in place to protect workersand the public from contact with the waste. Category B; Grade III
3. Medical waste, (e.g., gloves, sponges, dressings,surgical drapes soiled or soaked with blood orsecretions) may be contained in impervious wasteholding bags or double bags and may be disposed ofin a landfill(114,208,209). Category B; Grade III
4. Blood, suctioned fluids, excretions and secretionsmay be disposed of in a sanitary sewer if localregulations permit. Category B; Grade III
5. Anatomic waste, (e.g., tissues, organs, body parts)should be packaged in a sealed, impervious container that is not easily torn or penetrated in transport, andmay be disposed of in an incinerator or crematorium(Table 10). Category B; Grade III
6. Microbiologic waste, (e.g., diagnostic specimens,laboratory cultures, vaccines) should be packaged inincineration or autoclavable bags and treated byincineration or steam sterilization before disposal in a landfill. Adhere to Laboratory BiosafetyGuidelines(188,210). Category B; Grade III
7. Sharps (e.g., needles, syringes, blades, lancets,clinical glass) should be contained in puncture-resistant sharps containers for transport and treatedby incineration or landfill (home health care),depending on local regulations (Table 10)(211,218).Category A; Grade II
8. Isolation waste (waste containing pathogenscategorized as Risk Group 4 agents such as Lassafever, Marburg and Ebola viruses) must be containedin a Transport Canada approved, sealed, impervious
container for transport and should be treated byincineration. Under the Transportation of Dangerous Goods Regulations, Schedule 16, mandated byTransport Canada (TC), any shipment of a RiskGroup 4 agent must have a TC approved EmergencyResponse Assistance Plan in place beforeshipment(216). The local public health authority mustbe contacted(203). Category B; Grade III
9. A biohazard symbol is required on all wastepackaged for incineration. Regulations regardingcolour coding may vary provincially. Category B;Grade III
10. All transportation of infectious waste must complywith the Transportation of Dangerous Goods Act and Regulation, Transport Canada(216).
11. Infectious waste must be stored in a designatedlocation with access limited to authorized personnel.Refrigerated space should be provided for lockable,closed storage of laboratory waste that will bedisposed of off site(188). Provincial/territorialregulations for specific storage requirements shouldbe followed. Category B; Grade III
12. Health care facilities should choose waste hauling,treatment, and disposal firms carefully since thewaste generator is held directly accountable forensuring that all stages of transportation and disposalare carried out in a safe and legal manner(188).Category B; Grade III
13. Written policies and procedures to promote the safety of waste handlers should be established with inputfrom persons handling the waste. Category B;Grade III
14. Waste handlers should wear protective apparatusappropriate to the risk, (e.g., protective footwear andheavy work gloves). Category B; Grade III
15. Waste handlers should be offered hepatitis Bimmunization.
40
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Appendix 1
Glossary
Antimicrobial agent: a product that kills or suppressesthe growth of microorganisms.
Antiseptics: chemicals that kill microorganisms onliving skin or mucous membranes. Antiseptics should not be used in housekeeping.
Biofilm: the process of irreversible adhesion initiated bythe binding of bacteria to the surface by means ofexopolysaccharide material (glycocalyx). The develop-ment of adherent microcolonies leads eventually to theproduction of a continuous biofilm on the colonizedsurface. Bacteria within biofilms tend to be moreresistant to antibiotics and biocides than cells in batch-type culture.
Biomedical waste: defined by the CSA(210) as waste that is generated by human or animal health care facilities,medical or veterinary settings, health care teachingestablishments, laboratories, and facilities involved in the production of vaccines.
Cleaning: the physical removal of foreign material, e.g.,dust, soil, organic material such as blood, secretions,excretions and microorganisms. Cleaning physicallyremoves rather than kills microorganisms. It isaccomplished with water, detergents and mechanicalaction. The terms “decontamination” and “sanitation”may be used for this process in certain settings, e.g.,central service or dietetics. Cleaning reduces oreliminates the reservoirs of potential pathogenicorganisms. Cleaning agents are the most commonchemicals used in housekeeping activity.
Critical items: instruments and devices that enter steriletissues, including the vascular system. Critical itemspresent a high risk of infection if the item iscontaminated with any microorganisms, includingbacterial spores. Reprocessing critical items involvesmeticulous cleaning followed by sterilization.
Decontamination: the removal of disease-producingmicroorganisms to leave an item safe for furtherhandling.
Disinfection: the inactivation of disease-producingmicroorganisms. Disinfection does not destroy bacterialspores. Disinfectants are used on inanimate objects;antiseptics are used on living tissue. Disinfection usuallyinvolves chemicals, heat or ultraviolet light. Levels ofchemical disinfection vary with the type of product used.
Fomites: those objects in the inanimate environment that may become contaminated with microorganisms andserve as a vehicle of transmission(115).
Germicide: an agent that destroys microorganisms,especially pathogenic organisms.
Hand wash(ing): a process for the removal of soil andtransient microorganisms from the hands.
Hand antisepsis: a process for the removal ordestruction of resident and transient microorganisms onhands.
Heavy microbial soiling: the presence of infection orhigh levels of contamination with organic material, e.g.,infected wounds, feces.
High level disinfection: level of disinfection requiredwhen processing semicritical items. High leveldisinfection processes destroy vegetative bacteria,mycobacteria, fungi and enveloped (lipid) and nonenveloped (non lipid) viruses, but not necessarilybacterial spores. High level disinfectant chemicals (alsocalled chemisterilants) must be capable of sterilizationwhen contact time is extended. Items must be thoroughly cleaned prior to high level disinfection.
Infectious waste: that portion of biomedical waste thatis capable of producing infectious disease(219).
Intermediate level disinfection: level of disinfectionrequired for some semicritical items. Intermediate leveldisinfectants kill vegetative bacteria, most viruses andmost fungi but not resistant bacterial spores.
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Low level disinfection: level of disinfection requiredwhen processing noncritical items or someenvironmental surfaces. Low level disinfectants kill most vegetative bacteria and some fungi as well as enveloped(lipid) viruses (e.g., hepatitis B, C, Hantavirus, and HIV). Low level disinfectants do not kill mycobacteria orbacterial spores. Low level disinfectants-detergents areused to clean environmental surfaces.
Noncritical items: those that either touch only intactskin but not mucous membranes or do not directly touchthe patient. Reprocessing of noncritical items involvescleaning and/or low level disinfection.
Plain or nonantimicrobial soap: detergent-basedcleansers in any form (bar, liquid, leaflet, or powder)used for the primary purpose of physical removal of soiland contaminating microorganisms. Such soaps workprincipally by mechanical action and have weak or nobactericidal activity. Although some soaps contain lowconcentrations of antimicrobial ingredients, these areused as preservatives and have minimal effect oncolonizing flora.
Sanitation: a process that reduces microorganisms on an inanimate object to a safe level (e.g., dishes and eatingutensils are sanitized).
Semicritical items: devices that come in contact withnonintact skin or mucous membranes but ordinarily donot penetrate them. Reprocessing semicritical itemsinvolves meticulous cleaning followed preferably byhigh-level disinfection (level of disinfection required isdependent on the item, see Table 5). Depending on thetype of item and its intended use, intermediate leveldisinfection may be acceptable (see Table 5 forexamples).
Sharps: needles, syringes, blades, laboratory glass orother objects capable of causing punctures or cuts.
Sterilization: the destruction of all forms of microbiallife including bacteria, viruses, spores and fungi. Itemsmust be cleaned thoroughly before effective sterilizationcan take place.
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Appendix 2
Guideline Rating System
The Laboratory Centre for Disease Control (LCDC)Infection Control Guidelines previously used a systemfor rating guideline statements based on the strength ofthe evidence(15,71). A more elaborate system of rating hasrecently been proposed(223), with five categories to rankthe strength of the evidence for (categories A-C) oragainst (D-E) a statement, and three grades to describethe quality of supportive studies. This system of ratingfollows the guidelines that have been recently publishedfor clinical practice guidelines. The format uses anevidence-based medicine approach, which stresses theexamination of evidence from clinical research,especially randomized studies, and places less emphasison intuition and recalled experiences.
This new rating scheme, with one modification, isused in this document with appropriate clarification of
evidence described in the text. The modification occursin Category C with the word “insufficient” replacing“poor” in the original rating scheme. This system isoutlined in Table 11.
The information in these guidelines was current at thetime of publication; it should be emphasized that areas of knowledge and aspects of medical technology advancewith time. Guidelines, by definition, are directingprinciples and indications or outlines of policy orconduct, which should not be regarded as rigid standards. These guidelines should facilitate development ofstandards but respect the autonomy of organizations andrecognize their governing body's authority andresponsibility to ensure the quality of care provided bythe institution.
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Table 11: Strength and Quality of Evidence for Recommendations
Categories for strength of each recommendation
Category Definition
A Good evidence to support a recommendation for use.
B Moderate evidence to support a recommendation for use.
C Insufficient evidence to support a recommendation for or against use.
D Moderate evidence to support a recommendation against use.
E Good evidence to support a recommendation against use.
Categories for quality of evidence on which recommendations are made
Grade Definition
I Evidence from at least one properly randomized, controlled trial.
II Evidence from at least one well-designed clinical trial without randomization, from cohort or case-controlledanalytic studies, preferably from more than one centre, from multiple time series, or from dramatic results inuncontrolled experiments.
III Evidence from opinions of respected authorities on the basis of clinical experience, descriptive studies, orreports of expert committees.
Appendix 3
Drugs Directorate Guidelines
For more information regarding disinfectants and foran order form for publications of the Drugs Directorate,including the Drugs Directorate Guidelines, visit thewebsite at the following address:www.hc-sc.gc.ca/hpb-dgps/therapeut
For further information from the TherapeuticsProducts Programme, Bureau of PharmaceuticalAssessment, Health Protection Branch, Health Canada,telephone (613) 965-6466 and (613) 954-6503.
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